Calibrator, Secondary
FDA product code JIT · Class II (moderate risk) · 21 CFR 862.1150 · Clinical Chemistry
245510(k) clearances
0PMA approvals
55recalls
Manufacturers
- Dade Behring, Inc. 29
- Roche Diagnostics Corp. 18
- Wako Chemicals USA, Inc. 15
- Siemens Healthcare Diagnostics, Inc. 11
- E.I. Dupont DE Nemours & Co., Inc. 10
- Diamond Diagnostics, Inc. 9
- Beckman Coulter Inc. 8
- Kmn Products, Inc. 7
- Abbott Laboratories 6
- Reference Diagnostics, Inc. 5
- Fujirebio Diagnostics,Inc. 5
- Tosoh Bioscience Inc 5
- Olympus America, Inc. 4
- Ortho-Clinical Diagnostics 4
- Union Carbide Corp. 4
- Dade Chemistry Systems, Inc. 4
- American Dade 4
- Casco Standards 3
- Emd Chemicals, Inc. 3
- Sigma Diagnostics, Inc. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | Tosoh Bioscience, Inc. | 02/17/2016SE |
| K153417 | ST AIA-PACK PROG III Calibrator SetJIT · Traditional | Tosoh Bioscience, Inc. | 12/18/2015SE |
| K152526 | Elecsys Progesterone III CalSetJIT · Traditional | Roche Diagnostics | 10/02/2015SE |
| K151566 | Abbott ARCHITECT Total T4 CalibratorsJIT · Traditional | Abbott Laboratories | 07/10/2015SE |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL…JIT · Special | Beckman Coulter, Inc. | 02/26/2015SE |
| K143342 | Elecsys T-Uptake CalsetJIT · Traditional | Roche Diagnostics | 12/19/2014SE |
| K143144 | ST AIA-PACK PROG II Calibrator SetJIT · Traditional | Tosoh Bioscience, Inc. | 12/03/2014SE |
| K142181 | Randox Aldolase Calibration SerumJIT · Traditional | Randox Laboratories Limited | 09/18/2014SE |
| K142021 | Elecsys Estradiol III CalSetJIT · Traditional | Roche Diagnostics | 08/12/2014SE |
| K133751 | Diamond Diagnostics Ise Serum Standards, Diamond Diagnostics Ise Urine StandardsJIT · Traditional | Diamond Diagnostics, Inc. | 08/08/2014SE |
| K141728 | Ace CalibratorJIT · Abbreviated | SENTINEL CH. SpA | 07/28/2014SE |
| K141374 | Bicarbonate CalibratorJIT · Abbreviated | Beckman Coulter Ireland, Inc. | 06/30/2014SE |
| K140112 | Ca 125 II Calset IIJIT · Traditional | Roche Diagnostics | 06/06/2014SE |
| K140648 | ST Aia-Pack C-Peptide II Calibrator SetJIT · Abbreviated | Tosoh Bioscience, Inc. | 04/10/2014SE |
| K130603 | Pathfast CTNL CalibratorsJIT · Special | Mitsubishi Chemical Medience Corporation | 03/27/2014SE |
| K132400 | Lp(A) Calibrators, and Lp(A) ControlsJIT · Abbreviated | Biokit, S.A. | 12/19/2013SE |
| K130628 | Pathfast Ck-Mb-Ii CalibratorsJIT · Special | Mitsubishi Chemical Medience Corporation | 10/04/2013SE |
| K131556 | Diazyme Lipoprotein (a) Calibrator Set, Control SetJIT · Special | Diazyme Laboratories | 06/26/2013SE |
| K130698 | Dimension Vista Progesterone Calibrator (Prog Cal)JIT · Abbreviated | Siemens Healthcare Diagnostics | 04/05/2013SE |
| K122177 | Elitech Clinical Systems Urine Total Protein Plus Standard 100 Mg/Dl, Elitech Clinical…JIT · Abbreviated | Elitechgroup | 02/15/2013SE |
| K121027 | Diamond Calibrator Low, Diamond Calibrator HighJIT · Traditional | Diamond Diagnostics, Inc. | 12/20/2012SE |
| K120591 | Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2JIT · Traditional | Diamond Diagnostics, Inc. | 04/17/2012SE |
| K113373 | Dimension Vista Loci 9 Calibrator- Loci 9 CalJIT · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 12/30/2011SE |
| K111952 | Access Folate Calibrators on the Access Immunoassay Systems Model A98033JIT · Abbreviated | Beckman Coulter, Inc. | 08/19/2011SE |
| K111762 | ST Aia-Pack Dhea-S Calibrator SetJIT · Abbreviated | Tosoh Bioscience, Inc. | 08/05/2011SE |
| K111023 | Abbott Architect LH CalibratorsJIT · Traditional | Abbott Laboratories | 06/10/2011SE |
| K103548 | Advia Centaur Calibarator 80 Model 10492491JIT · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 06/02/2011SE |
| K110169 | Dimension Vista CDT Cal, Dimension Vista CDT Con L, Dimension Vista CDT Con HJIT · Traditional | Siemens Healthcare Diagnostics | 04/07/2011SE |
| K103836 | Enzyme II CalibratorJIT · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/16/2011SE |
| K103221 | Elecys HGH Calset, Elecsys HGH Calcheck 5JIT · Traditional | Roche Diagnostics | 12/23/2010SE |
| K103360 | Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional | Siemens Corp. | 12/17/2010SE |
| K102638 | Diazyme Homocysteine Assay Buffer Based CalibratorsJIT · Abbreviated | Diazyme Laboratories | 11/30/2010SE |
| K092937 | Sta-Hybrid Hep CalibratorJIT · Traditional | Diagnostica Stago, Inc. | 08/02/2010SE |
| K093357 | Diamond Medica Ise Module Calibrant a Model ME-6370D, Diamond Medica Ise Module…JIT · Traditional | Diamond Diagnostics, Inc. | 06/24/2010SE |
| K100293 | Advia Centaur Calibrator 30, Models 10379811/10379810JIT · Abbreviated | Siemens Heatlhcare Diagnostics, Inc. | 03/19/2010SE |
| K092570 | Abx Pentra Tpu Cal, Model A11A01898JIT · Abbreviated | Horiba Abx SAS | 10/16/2009SE |
| K083462 | Dimension Vista System Enzyme 5 Calibrator, Model KC350JIT · Traditional | Siemens Healthcare Diagnostics | 02/27/2009SE |
| K082680 | Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623JIT · Abbreviated | Siemens Healthcare Diagnostics | 10/10/2008SE |
| K081789 | Dimension Clinical Chemistry System Enzyme I CalibratorJIT · Traditional | Siemens Healthcare Diagnostics, Inc. | 09/10/2008SE |
| K082141 | Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10JIT · Abbreviated | Biokit, S.A. | 09/03/2008SE |
| K081319 | Dimension Clinical Chemistry System Lipase Calibrator, Model DC56JIT · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 08/04/2008SE |
| K081683 | Loci Cardiac Troponin I Calibrator, Model RC621JIT · Traditional | Siemens Healthcare Diagnostics | 07/07/2008SE |
| K080166 | Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545JIT · Special | Beckman Coulter, Inc. | 03/19/2008SE |
| K072717 | Dimension Vista System Bilirubin Calibrator, Model KC210JIT · Traditional | Dade Behring, Inc. | 12/12/2007SE |
| K071039 | Mission Olympus Au Ise CalibratorsJIT · Traditional | Diamond Diagnostics, Inc. | 08/08/2007SE |
| K070552 | Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)JIT · Traditional | Dade Behring, Inc. | 04/30/2007SE |
| K062521 | Oxalate Urine Controls (Normal and Elevated)JIT · Traditional | Thermo-Electron Corp. | 03/16/2007SE |
| K070144 | Inhibin a Calibrators & Controls on the Access Immunoassay SystemsJIT · Traditional | Beckman Coulter, Inc. | 02/01/2007SE |
| K060854 | Abx Pentra 400: LipoproteinsJIT · Traditional | Horiba Abx | 08/24/2006SE |
| K062152 | Creatinine Kinase MB Isoenzyme Verifier, Model DC27JIT · Traditional | Dade Behring, Inc. | 08/16/2006SE |
| K061885 | Dimension Vista System Total Triiodothyronine Calibrator, Model KC250JIT · Traditional | Dade Behring, Inc. | 08/14/2006SE |
| K061818 | Dimension Vista System Alkaline Phosphatase Calibrator (Alp Cal - KC330)JIT · Traditional | Dade Behring, Inc. | 07/18/2006SE |
| K061751 | Dimension Vista System Ucfp Calibrator, Model KC260JIT · Traditional | Dade Behring, Inc. | 07/13/2006SE |
| K061702 | Dimension Vista System Creatine Kinase Calibrator (CK Cal - KC340)JIT · Traditional | Dade Behring, Inc. | 07/10/2006SE |
| K061139 | Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsJIT · Abbreviated | Bayer Healthcare, LLC | 07/06/2006SE |
| K061282 | Access Ultrasensitive HGH Calibrator, Model 33585JIT · Special | Beckman Coulter, Inc. | 06/02/2006SE |
| K060140 | Crp-Advance Multi Calibrator Set, Model SE-250JIT · Traditional | Diagnostic Chemicals , Ltd. | 04/24/2006SE |
| K060754 | Elecsys TSH Calset W/Models 04738551JIT · Special | Roche Diagnostics Corp. | 04/18/2006SE |
| K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10JIT · Abbreviated | Denka Seiken Co., Ltd. | 04/14/2006SE |
| K060322 | Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry…JIT · Traditional | Cliniqa Corporation | 03/21/2006SE |
| K053291 | Ferritin Calibrator Set, Catalog No. 8203JIT · Abbreviated | Reference Diagnostics, Inc. | 03/13/2006SE |
| K060371 | The Emit 2000 Tacrolimus CalibratorsJIT · Traditional | Dade Behring, Inc. | 03/09/2006SE |
| K053576 | Dimension Vista Myo Reagent Cartridge and CalibratorJIT · Traditional | Dade Behring, Inc. | 02/07/2006SE |
| K053330 | Architect B12 CalibratorsJIT · Special | Abbott Laboratories | 12/16/2005SE |
| K052148 | Total Iron-Binding Capacity Calibrator Set. Direct Tibc Calibrator SetJIT · Abbreviated | Reference Diagnostics, Inc. | 11/09/2005SE |
| K052982 | Roche Diagnostics Cobas Elecsys Prolactin II CalsetJIT · Special | Roche Diagnostics | 10/28/2005SE |
| K052193 | Ise CompensatorJIT · Traditional | Roche Diagnostics | 10/03/2005SE |
| K052002 | Iron StandardJIT · Traditional | Roche Diagnostics Corp. | 08/22/2005SE |
| K051012 | Progesterone Standard Calibrator, One (1) ML of Progesterone in a Saliva-Like Matrix at…JIT · Traditional | Salimetrics, LLC | 07/19/2005SE |
| K050231 | Elecsys Ca 19-9 Immunoassay, Elecsys Ca 19-9 CalsetJIT · Traditional | Roche Diagnostics Corp. | 07/06/2005SE |
| K043378 | Drew Scientific Ltd. Glycated Haemoglobin Two Level Calibrator KitJIT · Abbreviated | Drew Scientific , Ltd. | 12/29/2004SE |
| K042838 | Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance…JIT · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/09/2004SE |
| K042406 | Olympus Lactate, OSR6193JIT · Traditional | Olympus America, Inc. | 12/03/2004SE |
| K043095 | Roche Diagnostics Elecsys Afp Calset IIJIT · Special | Roche Diagnostics Corp. | 11/23/2004SE |
| K042521 | Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…JIT · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/18/2004SE |
| K042307 | Architect T-Uptake Calibrators (A-F) and Controls (Low, High)JIT · Abbreviated | Seradyn, Inc. | 11/03/2004SE |
| K042651 | Free T3 Calibrators on the Access Immunoassay SystemsJIT · Traditional | Beckman Coulter, Inc. | 10/05/2004SE |
| K042490 | Elecsys Folate II Calset IIJIT · Special | Roche Diagnostics Corp. | 09/30/2004SE |
| K033860 | Autokit Total Ketone Bodies Kit (Serum) and Wako Ketone Body CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 04/23/2004SE |
| K040692 | Olympus HDL Cholesterol Reagent, OSR6195/OSR6295 and Olympus HDL Cholesterol Calibrator…JIT · Special | Olympus America, Inc. | 04/08/2004SE |
| K040226 | Wako Auto Kit Prealbumin, Wako Autokit Prealbumin Calibrator Set, Prealbumin Control SetJIT · Traditional | Wako Chemicals USA, Inc. | 03/25/2004SE |
| K040471 | Olympus LDL Cholesterol Reagent, OSR6196/OSR6296; Olympus LDL Cholesterol Calibrator…JIT · Special | Olympus America, Inc. | 03/10/2004SE |
| K033060 | Calibrating Material, Calibrating StandardsJIT · Traditional | Diamond Diagnostics, Inc. | 03/04/2004SE |
| K033786 | Luminescent Immunoassay Kit for the Detection of Testosterone in Serum and SalivaJIT · Traditional | Ibl GmbH | 02/27/2004SE |
| K033643 | CO2 Calibrator/DiluentJIT · Abbreviated | Bayer Healthcare, Diagnostics Division | 01/08/2004SE |
| K032458 | Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx…JIT · Abbreviated | Abbott Laboratories | 10/06/2003SE |
| K032285 | Olympus Prealbumin Calibrator, ODR3029JIT · Abbreviated | Olympus America, Inc. | 08/21/2003SE |
| K031924 | Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator…JIT · Traditional | Ortho-Clinical Diagnostics | 08/07/2003SE |
| K031159 | Calibrating Material, Calibrating StandardsJIT · Traditional | Diamond Diagnostics, Inc. | 06/25/2003SE |
| K031299 | Elecsys LH Calset IIJIT · Special | Roche Diagnostics Corp. | 05/12/2003SE |
| K030772 | Rdi Extended Range CRP Calibrator SetJIT · Abbreviated | Reference Diagnostics, Inc. | 04/11/2003SE |
| K022533 | Fastpack Testosterone CalibratorJIT · Abbreviated | Qualigen, Inc. | 09/30/2002SE |
| K022027 | Calibrating Material, Buffers, StandardJIT · Traditional | Mission Diagnostics | 07/22/2002SE |
| K021607 | Rdi HS CRP Calibrator SetJIT · Abbreviated | Reference Diagnostics, Inc. | 06/27/2002SE |
| K021535 | Advia Cantaur and ACS:180 Insulin CalibratorJIT · Traditional | Bayer Diagnostics Corp. | 06/27/2002SE |
| K021532 | Advia Centaur and ACS:180 C-Peptide CalibratorJIT · Traditional | Bayer Diagnostics Corp. | 06/27/2002SE |
| K020980 | Dimension Tpsa Calibrator, Model #RC459JIT · Traditional | Dade Behring, Inc. | 06/21/2002SE |
| K020723 | Dimension Aldl Calibrator, Model DC131JIT · Traditional | Dade Behring, Inc. | 05/08/2002SE |
| K020894 | Calibrating Material, Cal-Pak, BuffersJIT · Traditional | Mission Diagnostics | 04/29/2002SE |
| K020454 | Chemistry CalibratorJIT · Traditional | Jas Diagnostics, Inc. | 04/08/2002SE |
| K020596 | Calibrating Material,Cal-Pak, Cal & Slope StandardsJIT · Traditional | Diamond Diagnostics, Inc. | 03/23/2002SE |
| K013850 | Standard a, Standard B, Standard C, Cal, SlopeJIT · Traditional | Diamond Diagnostics, Inc. | 12/21/2001SE |
| K012900 | Access Unconjugated Estriol CalibratorsJIT · Traditional | Beckman Coulter, Inc. | 10/16/2001SE |
| K012367 | Vitamin D Test System Nichols Advantage 25-HYDROXYVITAMIN DJIT · Traditional | Nichols Institute Diagnostics | 10/09/2001SE |
| K012233 | Stratus CS Troponin I CalibratorJIT · Traditional | Dade Behring, Inc. | 09/11/2001SE |
| K012399 | Modification to Elecsys FSH II CalsetJIT · Special | Roche Diagnostics Corp. | 08/24/2001SE |
| K010332 | Wako Immunoassay Calibrator SetJIT · Traditional | Wako Chemicals USA, Inc. | 08/01/2001SE |
| K010334 | Wako Lipid CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 06/25/2001SE |
| K011126 | Raichem Creatinine Urine StandardJIT · Special | Hemagen Diagnostics, Inc. | 05/02/2001SE |
| K010314 | Dimension Ctni CalibratorJIT · Traditional | Dade Behring, Inc. | 04/20/2001SE |
| K003501 | N Protein Standard Uy CalibratorJIT · Traditional | Dade Behring, Inc. | 03/15/2001SE |
| K003411 | Elecsys Testosterone Calset IIJIT · Abbreviated | Roche Diagnostics Corp. | 03/01/2001SE |
| K010208 | Dimension Enzymatic Carbonate (ECO2) Calibrator, Catalog DC137JIT · Traditional | Dade Behring, Inc. | 02/20/2001SE |
| K003409 | Elecsys FSH Calset IIJIT · Abbreviated | Roche Diagnostics Corp. | 01/26/2001SE |
| K003096 | Fastpack CalibratorsJIT · Abbreviated | Qualigen, Inc. | 11/30/2000SE |
| K003098 | Access Ultrasensitive HGH CalibratorsJIT · Traditional | Beckman Coulter, Inc. | 11/20/2000SE |
| K000783 | Direct Tibc CalibratorJIT · Abbreviated | Reference Diagnostics, Inc. | 05/04/2000SE |
| K994291 | Dimension Special Protein CalibratorJIT · Traditional | Dade Behring, Inc. | 03/01/2000SE |
| K993132 | Genzyme Direct Amylase VerifierJIT · Abbreviated | Genzyme Corp. | 10/04/1999SE |
| K992981 | Elecsys Estradiol Calset IIJIT · Traditional | Roche Diagnostics Corp. | 09/24/1999SE |
| K991705 | N Protein Standard UyJIT · Traditional | Dade Behring, Inc. | 07/15/1999SE |
| K991176 | Opus Troponin I CalibratorJIT · Traditional | Dade Behring, Inc. | 07/01/1999SE |
| K990824 | Revised C-Reactive Protein CalibratorJIT · Traditional | Dade Behring, Inc. | 04/16/1999SE |
| K990554 | Dimension Special Protein CalibratorJIT · Traditional | Dade Behring, Inc. | 03/22/1999SE |
| K984193 | Dimensions RXL Myoglobin (Myo) CalibratorJIT · Traditional | Dade Behring, Inc. | 12/14/1998SE |
| K983850 | Dimension Ahdl CalibratorJIT · Traditional | Dade Behring, Inc. | 11/18/1998SE |
| K983722 | Stratus CS Troponin I CalibratorJIT · Traditional | Dade Behring, Inc. | 11/04/1998SE |
| K983693 | Dimensions (R) RXL Cardiac Troponin I CalibratorJIT · Traditional | Dade Behring, Inc. | 11/04/1998SE |
| K983548 | Ferritin CalibratorJIT · Traditional | Dade Behring, Inc. | 10/27/1998SE |
| K981854 | Olympus Serum Protein Multicalibrator,JIT · Traditional | Olympus Diagnostica GmbH | 08/18/1998SE |
| K982292 | Prealbumin CalibratorJIT · Traditional | Dade Behring, Inc. | 08/13/1998SE |
| K981100 | Stratus CS Trop CalpakJIT · Traditional | Dade Behring, Inc. | 04/16/1998SE |
| K981097 | Stratus CS CKMB CalpakJIT · Traditional | Dade Behring, Inc. | 04/16/1998SE |
| K981101 | Stratus CS Myo CalpakJIT · Traditional | Dade Behring, Inc. | 04/15/1998SE |
| K973668 | Cardiac Troponin-I (Trop) CalibratorJIT · Traditional | Dade Intl., Inc. | 10/20/1997SE |
| K973100 | Prostate Specific Antigen (Psa) CalibratorJIT · Traditional | Dade Chemistry Systems, Inc. | 09/29/1997SE |
| K964368 | Elecsys Cea AssayJIT · Traditional | Boehringer Mannheim Corp. | 06/16/1997SE |
| K970336 | MMB CalibratorJIT · Traditional | Dade Chemistry Systems, Inc. | 03/03/1997SE |
| K970389 | Thyroid CalibratorJIT · Traditional | Dade Chemistry Systems, Inc. | 02/18/1997SE |
| K963493 | Ferritin CalibratorJIT · Traditional | Dade Chemistry Systems, Inc. | 12/03/1996SE |
| K962594 | Aca Plus FT4 CalibratorJIT · Traditional | Dade Intl., Inc. | 08/15/1996SE |
| K954326 | STC Diagnostics Auto-Lyte Urinary Hemoglobin AssayJIT · Traditional | Solarcare Technologies Corp,Inc. | 07/23/1996SE |
| K952815 | Dupont Lipase CalibratorJIT · Traditional | Dupont Medical Products | 08/31/1995SE |
| K944516 | Fluids PackJIT · Traditional | Alko Diagnostic Corp. | 11/02/1994SE |
| K943704 | Lipase CalibratorJIT · Traditional | The DU Pont Co. | 09/14/1994SE |
| K934843 | Urinary/Cebrospinal Fluid Protein CalibratorJIT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/11/1994SE |
| K913371 | Total Iron and Unsat Iron Bind Capac/Iron Bind CalJIT · Traditional | Creative Laboratory Products, Inc. | 11/08/1991SE |
| K910962 | Cholesterol Calibrator SetJIT · Traditional | Casco Standards | 03/29/1991SE |
| K910160 | Electrophoresis ControlJIT · Traditional | Seradyn, Inc. | 02/27/1991SE |
| K904698 | Secondary CalibratorsJIT · Traditional | Bionostics, Inc. | 11/28/1990SE |
| K895649 | Coated Tube High Sensitivity TSH 200 Uiu/Ml Stan.JIT · Traditional | Ventrex Laboratories, Inc. | 01/18/1990SE |
| K895648 | Coated Tube High Sensitivity TSH 100 Uiu/Ml Stan.JIT · Traditional | Ventrex Laboratories, Inc. | 01/18/1990SE |
| K892329 | Osmometer Standard SolutionsJIT · Traditional | D.R.G. Scientific Industries | 10/31/1989SE |
| K891999 | Chloride Standards Item #SR1041JIT · Traditional | Em Diagnostic Systems, Inc. | 08/15/1989SE |
| K893139 | Document(Tm) Uric Acid Linearity Test SetJIT · Traditional | Casco Standards | 07/20/1989SE |
| K884197 | Document(Tm) Cholesterol Calibrator SetJIT · Traditional | Casco Standards | 12/14/1988SE |
| K882059 | Bilirubin StandardJIT · Traditional | Verichem Laboratories, Inc. | 10/25/1988SE |
| K883306 | Binas Luteinizing Hormone Irma Test KitJIT · Traditional | Binax, Inc. | 10/06/1988SE |
| K882259 | Dc-Bilitrol Catalogue # SE-021, SE-022, SE-023JIT · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 07/21/1988SE |
| K873743 | Paramax Ise Chloride CalibratorJIT · Traditional | Baxter Healthcare Corp | 12/14/1987SE |
| K871759 | G-Gt Standard CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 09/29/1987SE |
| K872073 | Bio-Interference Blanking Material, Am Cat. #2052JIT · Traditional | American Monitor Corp. | 09/11/1987SE |
| K872451 | Bile Acids CalibratorJIT · Traditional | Sigma Diagnostics, Inc. | 08/21/1987SE |
| K872263 | Total Bilirubin Standard CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 07/22/1987SE |
| K871756 | Creatinine Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/27/1987SE |
| K871768 | Uric Acid Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871767 | Urea N Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871766 | Triglyceride Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871765 | Phospholipids Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871764 | Inorganic Phosphorous Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871763 | Nefa Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871762 | Magnesium Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871758 | Glucose Standard Solution CalibratorJIT · Traditional | Wako Chemicals USA, Inc. | 05/26/1987SE |
| K871150 | Astra(Tm) Systems Triglycerides Calibrator 8JIT · Traditional | Beckman Instruments, Inc. | 05/26/1987SE |
| K870673 | Aca Human Chorionic Gonadotropin (HCG) CalibratorJIT · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/19/1987SE |
| K862525 | Emds(Tm) Dichrome QC Test Solution Item # 67447/95JIT · Traditional | Em Diagnostic Systems, Inc. | 08/19/1986SE |
| K861314 | Cholesterol CalibratorsJIT · Traditional | Sigma Diagnostics, Inc. | 07/01/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | Diagnostic Systems | 12/19/1985SE |
| K853887 | Liqui-Sera Chem. Multiple CalibratorsJIT · Traditional | Biodiagnostic Intl | 09/30/1985SE |
| K853533 | Absorbance Test SolutionJIT · Traditional | Diagnostic Systems | 09/16/1985SE |
| K852461 | Chemtrak Liquid Multi-Analyte Calibrator, Mul-SetJIT · Traditional | Medical Analysis Systems, Inc. | 07/12/1985SE |
| K852067 | Direct Biliruben CalibrationsJIT · Traditional | Data Medical Associates, Inc. | 05/31/1985SE |
| K851670 | Chem Trak Tri-Point Liquid Bilirubin Calibrator,I/JIT · Traditional | Medical Analysis Systems, Inc. | 05/10/1985SE |
| K844468 | Triglyceride CalibratorJIT · Traditional | Sigma Diagnostics, Inc. | 12/11/1984SE |
| K844047 | Fisher Diagnostics Sera Chem Smac CalibratorsJIT · Traditional | Fisher Diagnostics | 11/09/1984SE |
| K843112 | Roche Standards for Uric AcidJIT · Traditional | Roche Diagnostic Systems, Inc. | 09/13/1984SE |
| K842099 | Acth Standard MatrixJIT · Traditional | Diagnostic Systems Laboratories, Inc. | 08/17/1984SE |
| K840772 | Alcohol & Ammonia Calibrator IIJIT · Traditional | American Dade | 04/13/1984SE |
| K840771 | Alcohol & Ammonia Calibrator IJIT · Traditional | American Dade | 04/13/1984SE |
| K840775 | Carbon Dioxide Calibrator IIJIT · Traditional | American Dade | 04/04/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2894-2026 Class II | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | Aniara Diagnostica LLC | 07/01/2026Open, Classified |
| Z-1851-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT PROGESTERONE (100TESTS) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1850-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT FREE T4ABBDIA CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1849-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT TOTAL T36X4ML CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1848-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT VITAMIND 6LEVEL CALIBRATOR.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1593-2024 Class II | Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay…Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods… | Randox Laboratories Ltd. | 01/31/2024Open, 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… | Ortho-Clinical Diagnostics, Inc. | 11/21/2023Open, Classified |
| Z-2451-2023 Class II | ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in…There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting… | Siemens Healthcare Diagnostics, Inc. | 07/25/2023Open, 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… | Ortho-Clinical Diagnostics | 05/08/2023Open, Classified |
| Z-0102-2021 Class II | Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative…Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range… | Siemens Healthcare Diagnostics, Inc. | 09/22/2020Open, Classified |
| Z-0101-2021 Class II | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the…Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range… | Siemens Healthcare Diagnostics, Inc. | 09/22/2020Open, Classified |
| Z-2967-2020 Class II | Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number…Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting… | Tosoh Bioscience Inc | 08/07/2020Terminated |
| Z-1893-2020 Class III | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and…Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents… | Abbott Laboratories | 04/01/2020Terminated |
| Z-2078-2019 Class III | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the…Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP… | Abbott Laboratories | 05/24/2019Terminated |
| Z-1688-2020 Class II | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH…Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer… | Abbott Laboratories | 05/22/2019Terminated |
| Z-1361-2019 Class III | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1360-2019 Class III | ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1359-2019 Class III | ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1358-2019 Class III | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1356-2019 Class III | ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1355-2019 Class III | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1016-2019 Class II | Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the…The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control… | Randox Laboratories Ltd. | 12/03/2018Open, Classified |
| Z-0783-2019 Class II | Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens -…Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300… | Siemens Healthcare Diagnostics, Inc. | 09/26/2018Terminated |
| Z-0782-2019 Class II | Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens…Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300… | Siemens Healthcare Diagnostics, Inc. | 09/26/2018Terminated |
| Z-0781-2019 Class II | Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product…Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300… | Siemens Healthcare Diagnostics, Inc. | 09/26/2018Terminated |
| Z-0780-2019 Class II | Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens…Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica IM 1300… | Siemens Healthcare Diagnostics, Inc. | 09/26/2018Terminated |
| Z-1810-2018 Class II | Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended…The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1267-2018 Class II | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of…Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate… | Medica Corporation | 04/11/2017Terminated |
| Z-2085-2017 Class II | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number:…Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World… | Siemens Healthcare Diagnostics, Inc | 04/05/2017Terminated |
| 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… | Ortho-Clinical Diagnostics | 01/05/2017Terminated |
| Z-2282-2016 Class III | Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one…Instructions For Use had incorrect lot number and calibrator values | Tosoh Bioscience, Inc. | 06/07/2016Terminated |
| Z-1217-2017 Class III | The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine…Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension… | Siemens Healthcare Diagnostics, Inc. | 05/05/2016Terminated |
| 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… | Ortho-Clinical Diagnostics | 04/19/2016Terminated |
| Z-0202-2016 Class III | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040…The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash… | Ortho-Clinical Diagnostics | 09/28/2015Terminated |
| Z-0946-2015 Class II | Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro…Dimension Vista Myoglobin Calibrator (MYO CAL) may produce a positive shift in MYO QC and Patient test… | Siemens Healthcare Diagnostics, Inc. | 11/24/2014Terminated |
| Z-0024-2015 Class II | Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product…Siemens Healthcare Diagnostics has determined that Dimension Vista® Mass CKMB Isoenzyme Calibrator (MMB CAL)… | Siemens Healthcare Diagnostics, Inc. | 08/28/2014Terminated |
| Z-1804-2014 Class II | VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 --…Calibrator values assigned for the calibrator kit lots were released using a reference method that was… | Ortho-Clinical Diagnostics | 05/12/2014Terminated |
| Z-1671-2014 Class II | ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A…Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to… | Abbott Laboratories | 02/12/2014Terminated |
| Z-1193-2014 Class III | VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684…Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total… | Ortho-Clinical Diagnostics | 01/15/2014Terminated |
| Z-1926-2014 Class II | Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I…Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24%… | Siemens Healthcare Diagnostics, Inc. | 09/17/2013Terminated |
| Z-1925-2013 Class II | Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase…Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved… | Siemens Healthcare Diagnostics, Inc. | 06/05/2013Terminated |
| Z-1515-2013 Class II | ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Siemens Healthcare Diagnostics, Inc | 05/14/2013Terminated |
| Z-1514-2013 Class II | ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Siemens Healthcare Diagnostics, Inc | 05/14/2013Terminated |
| Z-0988-2013 Class III | Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in…Correlation slope bias and accuracy shift | Siemens Healthcare Diagnostics, Inc. | 10/10/2012Terminated |
| Z-0045-2013 Class II | IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box…It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with… | Immunodiagnostics Systems Ltd | 08/10/2012Terminated |
| Z-0047-2013 Class II | Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are…Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results… | Beckman Coulter Inc. | 07/24/2012Terminated |
| Z-0513-2012 | Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678)…Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients. | Siemens Healthcare Diagnostics, Inc. | 11/17/2011Terminated |
| Z-0971-2012 | VITROS Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name:…Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids… | Ortho-Clinical Diagnostics | 10/27/2011Terminated |
| Z-2226-2011 | SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman…The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the… | Beckman Coulter Inc. | 03/11/2011Terminated |
| Z-2178-2011 | Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904… | Beckman Coulter Inc. | 12/17/2009Terminated |