Ortho-Clinical Diagnostics
Medical device manufacturer in Rochester, NY.
142510(k) clearances
8PMA approvals
336recalls
Device types
- JJX Single (Specified) Analyte Controls… 13
- MMI Immunoassay Method, Troponin Subunit 6
- JJY Multi-Analyte Controls, All Kinds (Assayed) 5
- JFY Enzymatic Method, Creatinine 5
- JIT Calibrator, Secondary 4
- JIX Calibrator, Multi-Analyte Mixture 4
- DCK C-Reactive Protein, Antigen, Antiserum, And… 3
- KHS Enzymatic, Carbon-Dioxide 3
- JIS Calibrator, Primary 3
- CGZ Electrode, Ion-Specific, Chloride 3
- DHX System, Test, Carcinoembryonic Antigen 3
- CDN Urease, Photometric, Urea Nitrogen 2
- LTK Test, Epithelial Ovarian Tumor-Associated… 2
- LTJ Prostate-Specific Antigen (Psa) For… 2
- CGN Acid, Folic, Radioimmunoassay 2
- CIX Bromcresol Green Dye-Binding, Albumin 2
- DLZ Enzyme Immunoassay, Phenobarbital 2
- CDD Radioassay, Vitamin B12 2
- CGR Radioimmunoassay, Cortisol 2
- LOJ Kit, Test,Alpha-Fetoprotein For Testicular… 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | 08/13/2021SE |
| K200236 | VITROS BRAHMS PCT Reagent Pack and CalibratorsPMT · Traditional | 02/25/2020SE |
| K191316 | VITROS XT Chemistry Products ALB-TP SlidesCIX · Traditional | 06/07/2019SE |
| K190807 | VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional | 04/26/2019SE |
| K190520 | VITROS XT Chemistry Products GLU-Ca SlidesCGA · Traditional | 04/03/2019SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | 03/27/2019SE |
| K190326 | VITROS XT Chemistry Products UREA-CREA SlidesCDN · Traditional | 03/14/2019SE |
| K182072 | VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS…CGZ · Traditional | 10/30/2018SE |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS…JFY · Traditional | 10/30/2018SE |
| K163433 | VITROS Chemistry Products GLU SlidesCGA · Traditional | 09/18/2017SE |
| K160712 | VITROS Chemistry Products hsCRP ReagentDCK · Traditional | 07/14/2017SE |
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | 05/16/2017SE |
| K162020 | VITROS Chemistry Products Cl- SlidesCGZ · Traditional | 12/16/2016SE |
| K160495 | VITROS® Automation SolutionsKLI · Traditional | 10/18/2016SE |
| K161140 | VITROS Chemistry Products Calibrator Kit 3JIX · Abbreviated | 05/20/2016SE |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7DCK · Special | 09/24/2015SE |
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry…PDJ · Traditional | 06/04/2015SE |
| K130332 | Vitros Chemistry Products Trig SlidesCDT · Special | 05/31/2013SE |
| K123930 | Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers…LPS · Traditional | 05/15/2013SE |
| K121608 | Vitros Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack, Vitamin D Total…MRG · Traditional | 02/15/2013SE |
| K120765 | Vitros Chemistry Products ECO2 SlidesKHS · Special | 10/24/2012SE |
| K120609 | Vitros Chemistry Products DHDL SlidesLBS · Special | 09/07/2012SE |
| K101921 | Vitros Immunodiagnostics Products Intact PTH Reagent Pack, Vitros Immunodiagnostics…CEW · Traditional | 10/22/2010SE |
| K093611 | Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit…KHS · Traditional | 04/15/2010SE |
| K091861 | Vitros Chemistry Products Na + DT Slides, Model 153 2290 and DT Calibrator Kit, Model…JGS · Special | 09/03/2009SE |
| K072732 | Ortho T. Cruzi Elisa Test SystemMIU · Traditional | 04/15/2009SE |
| K083680 | Vitros Chemistry Products K+Dt Slides: Vitros Chemistry Products DT Calibrator Kit…CEM · Special | 02/27/2009SE |
| K083173 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 3600…JLW · Special | 12/22/2008SE |
| K081543 | Vitros Immunodiagnostic Products TSH Reagent Pack and Calibrators, Vitros 5600…JLW · Special | 10/23/2008SE |
| K082099 | Vitros Chemistry Products Ci-Dt Slides; Vitros Chemistry Products DT Calibrator Kit…CGZ · Special | 08/21/2008SE |
| K081411 | Vitros Chemistry Product Na+ Slides; Vitros Chemistry Products Calibrator Kit 2JGS · Special | 06/30/2008SE |
| K073157 | Vitros Chemistry Products K+ Slides and Calibrator Kit 2CEM · Special | 12/07/2007SE |
| K072443 | Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca AssayCJY · Special | 09/24/2007SE |
| K072440 | Vitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…CJY · Special | 09/20/2007SE |
| K071801 | Vitros Chemistry Products Ci-Slides, Calibrator Kit 2, Model(S) 844-5207, 166-2659JIX · Special | 07/20/2007SE |
| K071216 | Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit…JFY · Special | 05/25/2007SE |
| K071215 | Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit…JFY · Special | 05/25/2007SE |
| K063720 | Vitros Immunodiagnostic Products Total B-Hcg II Reagent Pack, Calibrators, Range VerifiersDHA · Traditional | 04/09/2007SE |
| K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DIS · Traditional | 01/05/2007SE |
| K063164 | Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat…LDJ · Traditional | 12/28/2006SE |
| K063143 | Vitros Immunodiagnostic Products Rubella Igg Reagant Pack and CalibratorsLFX · Traditional | 12/26/2006SE |
| K062285 | Vitros Chemistry Products Benz Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…JXM · Traditional | 12/22/2006SE |
| K062838 | Vitros Troponin I Es Assay, Including Reagent Pack, Calibrators and Range Verifiers…MMI · Traditional | 12/19/2006SE |
| K063591 | Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products…JFY · Special | 12/15/2006SE |
| K062460 | Vitros Chemistry Products Op Reagent, Calibrator Kit 26 and Dat Performance Verifiers I…DJG · Traditional | 12/15/2006SE |
| K062637 | Vitros Chemistry Products Metd Reagent, Calibrator Kit 26, Dat Performance, Verifiers I…DJR · Traditional | 11/22/2006SE |
| K062094 | Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat…LCM · Traditional | 11/22/2006SE |
| K062077 | Vitros Chemistry Products Amph Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DKZ · Traditional | 11/22/2006SE |
| K062123 | Vitros Chemistry Products Cocm Reagent, Calibrator Kit 26, FS Calibrator 1 and Dat…DIO · Traditional | 11/16/2006SE |
| K063144 | Vitros 5,1 FS Chemistry System with Engen Laboratory Automation SystemJJE · Special | 11/13/2006SE |
| K060770 | Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and ControlsLOL · Traditional | 09/15/2006SE |
| K060678 | Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,ControlsLOL · Traditional | 09/14/2006SE |
| K061588 | Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy…LPS · Traditional | 07/21/2006SE |
| K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism…CGR · Traditional | 07/03/2006SE |
| K061464 | Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668JMO · Special | 06/15/2006SE |
| K060632 | Vitros Immunodiagnostic Products NT Pro-Bnp Reagent Pack,Calibrators,Range VERIFIERS,680…NBC · Traditional | 06/06/2006SE |
| K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/Hpt…JIX · Traditional | 04/24/2006SE |
| K060650 | Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products…LCP · Special | 04/06/2006SE |
| K052867 | Vitros Chemistry Products Dtibc ReagentJMO · Traditional | 12/23/2005SE |
| K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…DEM · Traditional | 12/23/2005SE |
| K052645 | Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS…GTQ · Traditional | 12/14/2005SE |
| K043386 | Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers…LEH · Traditional | 02/07/2005SE |
| K043384 | Vitros Chemistry Products Tobra Reagent, Calibrator Kit 14 and TDM Performance Verifiers…LDO · Traditional | 02/07/2005SE |
| K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…LCD · Traditional | 01/06/2005SE |
| K042838 | Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…JIT · Traditional | 12/09/2004SE |
| K042476 | Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12…LEG · Traditional | 12/01/2004SE |
| K042520 | Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IIIKLS · Traditional | 11/30/2004SE |
| K042477 | Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20…DDG · Traditional | 11/19/2004SE |
| K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I…DCF · Traditional | 11/18/2004SE |
| K042521 | Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…JIT · Traditional | 11/18/2004SE |
| K042475 | Vitros Chemistry Products Igg, Iga and Igm Reagents; Vitros Chemistry Product Calibrator…CFN · Traditional | 11/10/2004SE |
| K042006 | Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…LBS · Traditional | 10/28/2004SE |
| K042494 | Vitros Chemistry Products C3 and CR Reagent, Calibrator Kit 20, Protein Performance…CZW · Traditional | 10/19/2004SE |
| K042303 | Vitros Immunodiagnostic Products Anti-Hbs ControlsJJX · Traditional | 09/27/2004SE |
| K041863 | Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16…DHR · Traditional | 09/20/2004SE |
| K041764 | The Vitros 5,1 FS Chemistry SystemLCP · Traditional | 09/09/2004SE |
| K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17…NQD · Traditional | 08/25/2004SE |
| K041720 | Vitros Chemistry Products DLDL Reagent, Calibrator Kit 19, FS Calibrator 1 and…MRR · Traditional | 08/25/2004SE |
| K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersDHX · Special | 06/17/2004SE |
| K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersDDR · Traditional | 11/05/2003SE |
| K033127 | Vitros Immunodiagnostic Products Anti-Hbc ControlsJJX · Traditional | 10/31/2003SE |
| K032993 | Vitros Immunodiagnostic Products Anti-Hbc Igm ControlsJJX · Traditional | 10/31/2003SE |
| K031031 | Vitros Immunodiagnostic Products Troponin I Reagent Pack and CalibratorsMMI · Traditional | 09/29/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | 08/13/2003SE |
| K031924 | Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator…JIT · Traditional | 08/07/2003SE |
| K030626 | Vitros Chemistry Products CRP Slide and Calibrator Kit 7DCK · Special | 03/18/2003SE |
| K024193 | Modification to Vitros Immundodiagnostic Products Troponin I Reagent Pack/CalibratorsMMI · Traditional | 02/21/2003SE |
| K030067 | Vitros Immunodiagnostic Products Hbsag ControlsMJX · Traditional | 01/17/2003SE |
| K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1JIX · Special | 12/10/2002SE |
| K023875 | Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4CIX · Special | 12/10/2002SE |
| K022901 | Vitros Immunodiagnostic Products Progesterone Reagent Pack and CalibratorsJIS · Special | 09/27/2002SE |
| K020662 | Modification to Vitros Immunodiagnostic Products Troponin I Reagent Pack/ CalibratorsMMI · Traditional | 04/12/2002SE |
| K013899 | Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3…CDD · Traditional | 01/24/2002SE |
| K013900 | Vitros Immunodiagnostic Products Vitamin B12 Range VerifiersJJX · Traditional | 12/21/2001SE |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special | 08/30/2001SE |
| K012561 | Vitros Immunodiagnostic Products Anti-Hcv ControlsJJX · Traditional | 08/29/2001SE |
| K011463 | Vitros Immunodiagnostic Products Folate Range VerifiersJJX · Special | 06/13/2001SE |
| K011250 | Vitros Immunodiagnostic Products Hbsag ControlsJJX · Traditional | 06/13/2001SE |
| K003112 | Vitros Immunodiagnostic Products Anti-Hbs ControlsJJX · Traditional | 11/02/2000SE |
| K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1CDN · Special | 07/20/2000SE |
| K001679 | Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3CIT · Special | 06/28/2000SE |
| K001769 | Vitros Chemistry Products Crea DT Slides; Vitros Chemistry Products DT Calibrator KitCGX · Special | 06/21/2000SE |
| K001310 | Vitros Chemistry Products Crea Slide, Virtros Chemistry Products Calibrator Kit 1JFY · Special | 05/05/2000SE |
| K001266 | Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitamin B12/FOLATE Reagent…CGN · Special | 05/02/2000SE |
| K001133 | Vitro Chemistry Products ECO2 Slide & Calibrator Kit 2KHS · Special | 04/24/2000SE |
| K000566 | Modofication to Vitro Immunodiagnostic Products Psa Reagent Pack, Vitro Immunodiagnostic…LTJ · Special | 03/09/2000SE |
| K994145 | Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products…JIS · Special | 12/22/1999SE |
| K992366 | Vitros Immunodiagnostic Products Troponin I Reagent PackMMI · Traditional | 10/08/1999SE |
| K993068 | Vitros Immunodiagnostic Products Ck-Mb Reagent Pack ; Vitros Immunodiagnostic Products…JHX · Special | 10/04/1999SE |
| K992349 | Vitros Immunodiagnostic Products Troponin I Range VerifiersJJY · Traditional | 08/24/1999SE |
| K990943 | Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea…DHX · Traditional | 06/01/1999SE |
| K990016 | Vitros Immunodiagnostic Products Anemia ControlsJJY · Traditional | 05/19/1999SE |
| K983875 | Vitros Immunodiagnostic Products Ca 125 II Calibrators, Vitros Immunodiagnostic Products…LTK · Traditional | 05/14/1999SE |
| K990984 | Vitros Immunodiagnostic Products Cea Range VerifiersJJX · Traditional | 04/08/1999SE |
| K990783 | Vitros Immunodiagnostic Products CA15-3 Range Verifiers, CA125 II Range Verifiers, Psa…JJX · Traditional | 03/25/1999SE |
| K990531 | Vitros Immunodiagnostic Products Oncology ControlsJJY · Traditional | 03/12/1999SE |
| K984289 | Vitros Immunodiagnostic Products Psa Calibrators, Vitros Immunodiagnostic Products Psa…LTJ · Traditional | 03/12/1999SE |
| K984166 | Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic…CGN · Traditional | 02/05/1999SE |
| K983690 | Vitros Immunodiagnostic Products Ca 15-3 Calibrators,Vitros Immunodiagnostic Products Ca…MOI · Traditional | 02/02/1999SE |
| K990026 | Vitros Immunodiagnostic Products Folate Verifiers, Vitros Immunodiagnostic Products…JJX · Traditional | 01/29/1999SE |
| K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX ControlsJMM · Traditional | 01/29/1999SE |
| K984303 | Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional | 01/28/1999SE |
| K984288 | Vitros Chemistry Products PHBR SlidesDLZ · Traditional | 01/26/1999SE |
| K990061 | Vitros Immunodiagnostic Products Afp Range VerifiersJJX · Traditional | 01/25/1999SE |
| K984321 | Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3…CDD · Traditional | 01/22/1999SE |
| K983990 | Vitros Immunodiagnostic Products Cortisol AssayCGR · Traditional | 12/29/1998SE |
| K983031 | Vitros Immunodiagnostic Products Afp AssayLOJ · Traditional | 12/18/1998SE |
| K984011 | Vitros Immunodiagnostic Products Cortisol Range VerifiersJJX · Traditional | 12/07/1998SE |
| K983507 | Vitros Immunodiagnostic Products Testosterone AssayJJY · Traditional | 11/04/1998SE |
| K983513 | Vitros Immunodiagnostic Products Range VerifiersJJY · Traditional | 11/03/1998SE |
| K982649 | Vitros Chemistry Products TDM Performance Verifiers I, II, and IIIDIF · Traditional | 08/12/1998SE |
| K973331 | Vitros Immunodiagnostic Products Ferritin Reagent Pack (GEM.1340), Ferritin Calibrators…DBF · Traditional | 10/22/1997SE |
PMA approvals
- P100001 Vitros Immunodiagnostic Products Anti-Hbe Reagent Pack/Anti-Hbe Calibrator/Anti Hbe Controls · 07/20/2011 · 17 supplements
- P090028 Vitros Immunodiagnostic Products Hbeag Reagent Pack/Products Hbeag Calibrator/Products Hbe Controls · 05/11/2011 · 17 supplements
- P030026 Vitros Immunodiagnostic Products Anti-Hbc Igm Reagent Pak/Calibrator · 03/04/2004 · 37 supplements
- P030024 Vitros Immunodiagnostic Products Anti-Hbc Reagent Pack/Calibrator · 03/04/2004 · 29 supplements
- P010021 Vitros Immunodiagnostic Products Anti-Hcv Reagent Pack and Calibrator · 08/30/2001 · 32 supplements
- P000044 Vitros Immunodiagnostic Products/Hbsag Reagent Pack,Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunr · 04/27/2001 · 40 supplements
- P000014 Vitros Immunodiagnostic Products:Anti-Hbs Reagent Pack/Anti-Hbs Calibrators · 09/29/2000 · 36 supplements
- P780006 Amersham Afp · 06/07/1984 · 2 supplements
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2560-2025 Class II | VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5…VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an… | 07/29/2025Open, Classified |
| Z-2559-2025 Class II | Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5…VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an… | 07/29/2025Open, Classified |
| Z-2335-2025 Class II | VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code… | 07/09/2025Open, Classified |
| Z-2073-2025 Class II | VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP…Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected… | 06/12/2025Open, Classified |
| Z-2123-2025 Class II | VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides)…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | 06/10/2025Open, Classified |
| Z-2122-2025 Class II | VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2)…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | 06/10/2025Open, Classified |
| Z-2121-2025 Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | 06/10/2025Open, Classified |
| Z-2120-2025 Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products…Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of… | 06/10/2025Open, Classified |
| Z-2040-2025 Class II | Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1)…a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the… | 05/09/2025Open, Classified |
| Z-2039-2025 Class II | Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog…a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the… | 05/09/2025Open, Classified |
| Z-2038-2025 Class II | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1)…A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the… | 05/09/2025Open, Classified |
| Z-1876-2025 Class II | VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides…Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge… | 04/14/2025Open, Classified |
| Z-1948-2025 Class II | Brand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella kit…It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated… | 03/24/2025Open, Classified |
| Z-1007-2025 Class II | Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog…The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal… | 12/19/2024Open, Classified |
| Z-1006-2025 Class II | Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number:…The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal… | 12/19/2024Open, Classified |
| Z-1005-2025 Class II | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number:…The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal… | 12/19/2024Open, Classified |
| Z-0535-2025 Class II | VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures…May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less… | 10/11/2024Open, Classified |
| Z-2684-2024 Class II | The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an…The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides… | 07/10/2024Open, Classified |
| Z-2580-2024 Class II | VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of… | 07/03/2024Open, Classified |
| Z-2266-2024 Class II | VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product…VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used… | 05/21/2024Open, Classified |
| Z-2245-2024 Class III | VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1…Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot… | 05/14/2024Open, Classified |
| Z-2019-2024 Class III | VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use…The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level… | 05/08/2024Open, Classified |
| Z-2142-2024 Class II | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator…Potential for positively biased results due to signal reduction over shelf life. | 03/01/2024Open, Classified |
| Z-1373-2024 Class II | VITROS Performance Verifier IIThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II.… | 02/27/2024Open, Classified |
| Z-1372-2024 Class II | VITROS Performance Verifier IThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II.… | 02/27/2024Open, Classified |
| Z-1233-2024 Class II | VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1232-2024 Class II | VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1231-2024 Class II | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1230-2024 Class II | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1229-2024 Class II | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914…A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the… | 01/26/2024Open, Classified |
| Z-1228-2024 Class II | VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1227-2024 Class II | VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1226-2024 Class II | VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1225-2024 Class II | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1224-2024 Class II | VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914…A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline… | 01/26/2024Open, Classified |
| Z-1222-2024 Class II | VITROS XT7600 Integrated SystemPotential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600… | 01/22/2024Open, Classified |
| Z-1221-2024 Class II | VITROS 5600 Integrated System (New and Refurbished)Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600… | 01/22/2024Open, Classified |
| Z-1220-2024 Class II | VITROS 3600 Immunodiagnostic System (New and Refurbished)Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600… | 01/22/2024Open, Classified |
| Z-0772-2024 Class II | VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925…Affected lots may experience increased calibration failures or an increase in falsely elevated results. | 11/27/2023Open, Classified |
| Z-0712-2024 Class II | QMS Tacrolimus Calibrators, Product code 10015573Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11… | 11/21/2023Open, Classified |
| Z-0510-2024 Class II | VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry…Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598… | 10/25/2023Open, Classified |
| Z-0547-2024 Class II | VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0546-2024 Class II | VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0545-2024 Class II | VITROS 5600 Integrated System Product Code 6802413 and Refurbished Product Code 6802915…During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0544-2024 Class II | VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440…During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0543-2024 Class II | VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code…During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software… | 10/10/2023Open, Classified |
| Z-0236-2024 Class II | VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per…Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to… | 09/12/2023Open, Classified |
| Z-0008-2024 Class II | Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System…Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between… | 08/09/2023Open, Classified |
| Z-2624-2023 Class II | VITROS XT Chemistry Products ALKP SlidesSamples containing high levels of ALKP (or an interfering substance) could deplete the available substrate… | 08/05/2023Open, Classified |
| Z-2623-2023 Class II | VITROS XT Chemistry Products TBIL-ALKP SlidesSamples containing high levels of ALKP (or an interfering substance) could deplete the available substrate… | 08/05/2023Open, Classified |
| Z-2358-2023 Class II | VITROS Immunodiagnostic Products Troponin I ES CalibratorsReagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially… | 06/05/2023Open, Classified |
| Z-2357-2023 Class II | VITROS Immunodiagnostic Products Troponin I ES Reagent PackReagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially… | 06/05/2023Open, Classified |
| Z-2225-2023 Class III | VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic…May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). | 05/18/2023Open, Classified |
| Z-2129-2023 Class II | VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS…Potential to cause biased results in the upper end of the reportable range for the quantitative measurement… | 05/08/2023Open, Classified |
| Z-1628-2023 Class II | VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of…Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis | 04/17/2023Open, Classified |
| Z-1664-2023 Class II | VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with…Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of… | 04/14/2023Open, Classified |
| Z-1557-2023 Class II | VITROS 5600 Integrated System - Refurbished . For use in the in vitro quantitative…MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT… | 03/10/2023Open, Classified |
| Z-1556-2023 Class II | VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative…MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT… | 03/10/2023Open, Classified |
| Z-1555-2023 Class II | VITROS XT 7600 Integrated System - For use in the in vitro quantitative…MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS 5600 and XT… | 03/10/2023Open, Classified |
| Z-1396-2023 Class II | VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed…Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2… | 03/09/2023Open, Classified |
| Z-0878-2023 Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative…Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results-… | 11/17/2022Open, Classified |
| Z-0220-2023 Class II | VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides For in vitro…Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for… | 10/13/2022Open, Classified |
| Z-1676-2022 Class II | VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative… | 07/19/2022Open, Classified |
| Z-1675-2022 Class II | VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative… | 07/19/2022Open, Classified |
| Z-1367-2022 Class II | Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS ECi/ECiQ/3600…On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the… | 05/26/2022Open, Classified |
| Z-1114-2022 Class II | VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic… | 03/25/2022Open, Classified |
| Z-1113-2022 Class II | VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic… | 03/25/2022Open, Classified |
| Z-1112-2022 Class II | VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic… | 03/25/2022Open, Classified |
| Z-0735-2022 Class II | VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is…The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent… | 12/10/2021Open, Classified |
| Z-0503-2022 Class II | VITROS Immunodiagnostic Products High Sample Diluent A Reagent PackLower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS… | 11/22/2021Open, Classified |
| Z-0247-2022 Class III | VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 For use in…Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM… | 10/15/2021Terminated |
| Z-0120-2022 Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For…VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control… | 09/10/2021Terminated |
| Z-1688-2021 Class II | VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent…Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes… | 05/03/2021Terminated |
| Z-1489-2021 Class II | VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference…Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as… | 03/26/2021Terminated |
| Z-1295-2021 Class II | VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to…Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the… | 02/18/2021Terminated |
| Z-1267-2021 Class II | VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2…VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT… | 02/12/2021Terminated |
| Z-1266-2021 Class II | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The…VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using Remel M4RT… | 02/12/2021Terminated |
| Z-1136-2021 Class II | VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to…A deformity affecting a specific lot of VITROS Chemistry Products VersaTips. Deformed VersaTips results may… | 01/14/2021Terminated |
| Z-0845-2021 Class II | VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively…Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP… | 12/15/2020Terminated |
| Z-0844-2021 Class II | VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in…Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Products ALB-TP… | 12/15/2020Terminated |
| Z-0770-2021 Class II | VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide cartridge)…VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference | 12/11/2020Open, Classified |
| Z-0801-2021 Class II | VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage:…A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to… | 11/20/2020Terminated |
| Z-0800-2021 Class II | enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product…A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to… | 11/20/2020Terminated |
| Z-0471-2021 Class III | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use…Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot… | 10/16/2020Open, Classified |
| Z-0451-2021 Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in…Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic… | 09/30/2020Terminated |
| Z-0450-2021 Class II | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro…Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic… | 09/30/2020Terminated |
| Z-2879-2020 Class II | VITROS XT7600 Integrated System, Product code 6844461When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result… | 07/20/2020Terminated |
| Z-2878-2020 Class II | VITROS XT3400 Chemistry System, Product code 6844458When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. As a result… | 07/20/2020Terminated |
| Z-2771-2020 Class II | VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919…The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or… | 07/17/2020Terminated |
| Z-2770-2020 Class II | VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI…The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or… | 07/17/2020Terminated |
| Z-2875-2020 Class II | VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | 07/13/2020Terminated |
| Z-2874-2020 Class II | VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | 07/13/2020Terminated |
| Z-2873-2020 Class II | VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic…Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT… | 07/13/2020Terminated |
| Z-2484-2020 Class II | VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461…Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default… | 05/20/2020Terminated |
| Z-2483-2020 Class II | VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product…Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default… | 05/20/2020Terminated |
| Z-2482-2020 Class II | VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413…Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default… | 05/20/2020Terminated |
| Z-2481-2020 Class II | VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique…Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default… | 05/20/2020Terminated |
| Z-2480-2020 Class II | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code:…Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default… | 05/20/2020Terminated |
| Z-2367-2020 Class II | VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | 05/11/2020Terminated |
| Z-2366-2020 Class II | VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI #…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | 05/11/2020Terminated |
| Z-2365-2020 Class II | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product Code…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | 05/11/2020Terminated |
| Z-2364-2020 Class II | VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code…Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when… | 05/11/2020Terminated |
| Z-1931-2020 Class II | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90…The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is… | 04/01/2020Terminated |
| Z-1930-2020 Class II | VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300…The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is… | 04/01/2020Terminated |
| Z-1834-2020 Class III | VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. | 03/10/2020Terminated |
| Z-1226-2020 Class II | VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1…Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator… | 12/16/2019Terminated |
| Z-0740-2020 Class II | Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine…Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine… | 10/14/2019Terminated |
| Z-0739-2020 Class II | 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute…Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine… | 10/14/2019Terminated |
| Z-0269-2020 Class II | VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which contain…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | 09/10/2019Terminated |
| Z-0268-2020 Class II | VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT support Urine…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | 09/10/2019Terminated |
| Z-0267-2020 Class II | VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Urine CL-).…Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen… | 09/10/2019Terminated |
| Z-2185-2019 Class II | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry…Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2184-2019 Class II | VITROS 5,1 FS Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2183-2019 Class II | VITROS 5,1 FS Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2182-2019 Class II | VITROS 4600 Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2181-2019 Class II | VITROS 4600 Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2180-2019 Class II | VITROS 5600 Integrated System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2179-2019 Class II | VITROS 5600 Integrated System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2178-2019 Class II | VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry…Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2177-2019 Class II | VITROS 350 Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2176-2019 Class II | VITROS 250AT Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2175-2019 Class II | VITROS 250 Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2174-2019 Class II | VITROS 250 Chemistry System, clinical chemistry analyzerPotential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 07/08/2019Terminated |
| Z-2202-2019 Class II | VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chemistry Products…Potentially Biased Results using VITROS Chemistry Products GLU Slides | 06/17/2019Terminated |
| Z-1936-2019 Class II | VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage:…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |
| Z-1935-2019 Class II | VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330)…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |
| Z-1934-2019 Class II | VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |
| Z-1933-2019 Class II | VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage:…Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Systems. | 04/08/2019Terminated |
| Z-1364-2019 Class II | VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product…Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading… | 03/20/2019Terminated |
| Z-1222-2019 Class II | VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage:…One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of… | 03/11/2019Terminated |
| Z-1293-2019 Class II | VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1292-2019 Class II | VITROS ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1291-2019 Class II | VITROS XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1290-2019 Class II | VITROS 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1289-2019 Class II | VITROS 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1288-2019 Class II | VITROS 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-1287-2019 Class II | VITROS 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in…Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems | 02/20/2019Terminated |
| Z-0992-2019 Class II | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use…Imprecision in the affected lot may produce negatively or positively biased patient sample and quality… | 01/22/2019Terminated |
| Z-0848-2019 Class II | VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG…Negative bias results when using VITROS VALP Reagent, GEN 25. | 12/11/2018Terminated |
| Z-0844-2019 Class II | Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the…A stability issue in the calibrators may cause calibration failures or atypical Quality Control results… | 11/29/2018Terminated |
| Z-0689-2019 Class II | VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use…The firm is extending their previous July 2018 recall to include additional product codes. Biased results… | 11/01/2018Open, Classified |
| Z-0688-2019 Class II | VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative…The firm is extending their previous July 2018 recall to include additional product codes. Biased results… | 11/01/2018Open, Classified |
| Z-0687-2019 Class II | VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro…The firm is extending their previous July 2018 recall to include additional product codes. Biased results… | 11/01/2018Open, Classified |
| Z-0653-2019 Class II | VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |
| Z-0652-2019 Class II | VITROS 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |
| Z-0651-2019 Class II | VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |
| Z-0650-2019 Class II | VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro…Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | 10/19/2018Terminated |
| Z-0476-2019 Class II | VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to…VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results | 10/08/2018Terminated |
| Z-0392-2019 Class II | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489…The reagent pack exhibits the potential for an increased frequency of calibration failures. | 08/28/2018Terminated |
| Z-0080-2019 Class II | VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative…Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide… | 08/15/2018Terminated |
| Z-0079-2019 Class II | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative…Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide… | 08/15/2018Terminated |
| Z-0061-2019 Class II | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |
| Z-0060-2019 Class II | VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |
| Z-0059-2019 Class II | VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |
| Z-0058-2019 Class II | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |
| Z-3193-2018 Class III | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA…The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of… | 07/11/2018Terminated |
| Z-3184-2018 Class III | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl…The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of… | 07/11/2018Terminated |
| Z-3044-2018 Class III | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro…The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when… | 07/11/2018Terminated |
| Z-3043-2018 Class III | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro…The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when… | 07/11/2018Terminated |
| Z-2344-2018 Class II | VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnosticThere is a potential for imprecise results when using the slides. Increase in imprecision when using PHYT… | 05/09/2018Terminated |
| Z-3280-2018 Class II | VITROS Sodium Slides, Catalog # 837 9034Potential for positively biased results | 05/05/2018Terminated |
| Z-0915-2018 Class II | VITROS Chemistry Products DAT Performance Verifier V in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0914-2018 Class II | VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0913-2018 Class II | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0912-2018 Class II | VITROS Chemistry Products DAT Performance Verifier II in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0911-2018 Class II | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnosticThis product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers… | 09/22/2017Terminated |
| Z-0807-2018 Class III | VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor…VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST… | 07/10/2017Terminated |
| Z-0273-2018 Class II | VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD…The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide… | 06/12/2017Terminated |
| Z-0254-2018 Class II | enGen Track System with TCAutomation Software Version 4.2A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to… | 04/26/2017Terminated |
| Z-2077-2017 Class II | enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions…Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics… | 03/08/2017Terminated |
| Z-1765-2017 Class II | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD ---…Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots… | 03/07/2017Terminated |
| Z-1887-2017 Class II | VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No.…Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after… | 02/21/2017Terminated |
| Z-1471-2017 Class II | VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660…Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. | 02/01/2017Terminated |
| Z-1181-2017 Class III | VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD; used in…The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL… | 01/05/2017Terminated |
| Z-1117-2017 Class II | VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+…There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using… | 12/20/2016Terminated |
| Z-1179-2017 Class II | VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative…There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO… | 12/08/2016Terminated |
| Z-0864-2017 Class III | VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit)…CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent… | 10/26/2016Terminated |
| Z-0903-2017 Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 /…The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In… | 10/05/2016Terminated |
| Z-0300-2017 Class II | enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo…Ortho confirmed that it is possible for the mis-association of sample identification and assay results due… | 09/07/2016Terminated |
| Z-0092-2017 Class II | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |
| Z-0091-2017 Class II | VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |
| Z-0090-2017 Class II | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |
| Z-0089-2017 Class II | VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales…Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose… | 08/11/2016Terminated |
| Z-2580-2016 Class III | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191…A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected… | 07/28/2016Terminated |
| Z-2352-2016 Class II | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No.…Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagent assay.… | 07/14/2016Terminated |
| Z-0313-2017 Class III | VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro…The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5… | 06/22/2016Terminated |
| Z-2302-2016 Class II | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468…Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products… | 06/02/2016Terminated |
| Z-2119-2016 Class III | VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in…Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC… | 05/24/2016Terminated |
| Z-2273-2016 Class II | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Unique Device…Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when… | 05/18/2016Terminated |
| Z-2143-2016 Class III | enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select…If the user selects the Comment or Interpretation option (in the enGEN .gsb file), and the numerical results… | 05/16/2016Terminated |
| Z-2145-2016 Class III | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique…Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP… | 05/09/2016Terminated |
| Z-2804-2016 Class III | The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with:…There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a… | 04/19/2016Terminated |
| Z-1914-2016 Class II | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No.…Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may… | 04/06/2016Terminated |
| Z-1913-2016 Class II | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro…Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may… | 04/06/2016Terminated |
| Z-1569-2016 Class II | enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper…The electrical cable that supplies power to the cap vibratory feeder of the Recapper Module may loosen from… | 03/17/2016Terminated |
| Z-1700-2016 Class II | 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device…When testing was conducted using certain lots, VITROS Systems generated results within the measuring range… | 02/18/2016Terminated |
| Z-1348-2016 Class II | VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 &…The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where… | 02/16/2016Terminated |
| Z-1075-2016 Class II | VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |
| Z-1074-2016 Class II | VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |
| Z-1073-2016 Class II | VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number…Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry… | 12/21/2015Terminated |