Single (Specified) Analyte Controls (Assayed And Unassayed)
FDA product code JJX · Class I (low risk) · 21 CFR 862.1660 · Clinical Chemistry
493510(k) clearances
0PMA approvals
41recalls
Manufacturers
- Roche Diagnostics Corp. 60
- Siemens Healthcare Diagnostics, Inc. 34
- Boehringer Mannheim Corp. 24
- Bionostics, Inc. 22
- Bio-Rad 21
- Ortho-Clinical Diagnostics 13
- Casco Standards 10
- Tosoh Medics, Inc. 10
- Diagnostic Products Corp. 9
- Streck Laboratories, Inc. 9
- Aalto Scientific, Ltd. 9
- Beckman Coulter Inc. 9
- Cliniqa Corporation 8
- Behring Diagnostics, Inc. 7
- Fujirebio Diagnostics,Inc. 7
- Beckman Instruments, Inc. 6
- Maine Standards Co. 6
- Immunodiagnostic Systems , Ltd. 6
- Sa Scientific, Inc. 6
- Quantimetrix Corp. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5JJX · Traditional | Roche Diagnostics | 04/04/2017SE |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5JJX · Traditional | Roche Diagnostics | 01/12/2017SE |
| K162514 | Multichem A1cJJX · Abbreviated | Technopath Manufacturing | 10/26/2016SE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | Aalto Scientific, Ltd. | 08/10/2016SE |
| K161526 | LIAISON CMV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161522 | LIAISON EBV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | Immunodiagnostic Systems , Ltd. | 05/17/2016SE |
| K152117 | Dropper hsCRP High Sensitivity CRP ControlJJX · Traditional | Quantimetrix Corporation | 04/21/2016SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2015SE |
| K150955 | Elecsys Progesterone III Cal Check 5JJX · Traditional | Roche Diagnostics | 05/01/2015SE |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control ModuleJJX · Traditional | Siemens Healthcare Diagnostics | 04/13/2015SE |
| K143324 | IDS-iSYS CTX-I Calibration VerifiersJJX · Traditional | Immunodiagnostic Systems , Ltd. | 03/30/2015SE |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 02/26/2015SE |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/25/2015SE |
| K143680 | ADVIA Centaur IgE Master Curve MaterialJJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/27/2015SE |
| K143639 | IMMULITE 2000 CEA Calibration Verification MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics | 01/23/2015SE |
| K143571 | Audit MicroControls Linearity LQ Cystatin-CJJX · Traditional | Aalto Scientific, Ltd. | 01/23/2015SE |
| K143504 | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/14/2015SE |
| K143352 | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 12/24/2014SE |
| K143376 | ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 12/23/2014SE |
| K143296 | AIA-PACK C-Peptide Control SetJJX · Traditional | Tosoh Bioscience, Inc. | 12/16/2014SE |
| K143284 | Elecsys Estradiol III CalcheckJJX · Traditional | Roche Diagnostics | 12/16/2014SE |
| K143194 | ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/05/2014SE |
| K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding CapacityJJX · Traditional | Aalto Scientific, Ltd. | 11/21/2014SE |
| K142878 | IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 10/30/2014SE |
| K142864 | ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI)…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/29/2014SE |
| K142811 | IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/29/2014SE |
| K142127 | Elecsys Estradiol III Calcheck 5JJX · Traditional | Roche Diagnostics | 09/05/2014SE |
| K141772 | Immulte 2000 Rubella Quantitative Igg Calibration Verification MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 08/19/2014SE |
| K141444 | Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 07/09/2014SE |
| K133816 | Immulite 2000 Free Psa Calibration Verification MaterialJJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 06/24/2014SE |
| K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 05/01/2014SE |
| K140541 | Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 04/01/2014SE |
| K140505 | Advia Centaur Vitamin B12 Master Curve Material, Total HCG Master Curve Material, and…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 03/31/2014SE |
| K140534 | Elecsys Precicontrol TSJJX · Traditional | Roche Diagnostics | 03/27/2014SE |
| K140267 | Advia Centaur Tni-Ultra Master Curve Material (MCM), Advia Centaur Digoxin Master Curve…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 03/10/2014SE |
| K140258 | Immulite 2000 DHEA-SO4; Third Generation TSH and Intact PTH Calibration Verification…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 03/05/2014SE |
| K133550 | Validate Ferritin Calibration Verification/ Linearity Test KitJJX · Traditional | Maine Standards Company, LLC | 02/05/2014SE |
| K133197 | Fdi Level I and Level II Glucose Controls for the Embrace No CodeJJX · Traditional | Fujirebio Diagnostics,Inc. | 01/17/2014SE |
| K132739 | Immulite 2000 Afp, Br-Ma, and Om-Ma Calibration Verification MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 01/14/2014SE |
| K133284 | Elecsys Ck-Mb Calcheck 5JJX · Traditional | Roche Diagnostics | 11/22/2013SE |
| K133122 | Immulite 2000; 3GALLERGY Specific Ige Control Verification Material (CVM), Total Ige…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 10/30/2013SE |
| K133124 | Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 10/25/2013SE |
| K133003 | Rightest Control SolutionJJX · Traditional | Bionime Corporation | 10/24/2013SE |
| K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…JJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 10/22/2013SE |
| K131662 | Immulite 2000 Acth Calibration Verification MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 10/10/2013SE |
| K132391 | Immulite 2000 Anti-Tg AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB…JJX · Abbreviated | Siemens Helathcare Diagnostics, Inc. | 09/20/2013SE |
| K131536 | Immulite 2000 Psa Calibration Verification MaterialJJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 08/12/2013SE |
| K131999 | HBA1C Control, Level 1 and Level 2JJX · Traditional | Randox Laboratories, Ltd. | 07/26/2013SE |
| K131776 | Aldolase Controls Level 2, and Aldolase Control Level 3JJX · Traditional | Randox Laboratories, Ltd. | 07/18/2013SE |
| K123127 | Validate Psa Calibration Verification/ Linearity Test Kit Model 406JJX · Traditional | Maine Standards Co. | 06/14/2013SE |
| K131136 | Glucose Meter-Check Solution for TaidocJJX · Traditional | Bionostics, Inc. | 05/31/2013SE |
| K130764 | Audit Microcv Vitamin D Linearity SetJJX · Traditional | Aalto Scientific, Ltd. | 04/26/2013SE |
| K130157 | Audit Microcv Beta-Hydroxybutyric Acid Linearity SetJJX · Traditional | Aalto Scientific, Ltd. | 03/19/2013SE |
| K122534 | Immulite 1000 Third Generation Psa Calibration Verification MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 03/14/2013SE |
| K123851 | Glucose Meter-Check Solution for Roche Accu-ChekJJX · Traditional | Bionostics, Inc. | 02/14/2013SE |
| K123966 | Glucose Meter-Check Solution for BayerJJX · Traditional | Bionostics, Inc. | 01/25/2013SE |
| K123612 | Fdi Glucose Control Solution for Use with Accu-Chek AvivaJJX · Traditional | Fujirebio Diagnostics,Inc. | 01/17/2013SE |
| K123798 | Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel MinipakJJX · Traditional | Bio-Rad Laboratories | 01/09/2013SE |
| K122242 | Elecsys Ca 15-3 II Calcheck 5JJX · Traditional | Roche Diagnostics | 12/05/2012SE |
| K121895 | Elecsys HSV-2 Igg ImmunoassayJJX · Traditional | Roche Diagnostics | 08/24/2012SE |
| K122141 | Ids-Isys Igf-I Calibration VerifiersJJX · Abbreviated | Immunodiagnostic Systems , Ltd. | 08/07/2012SE |
| K121746 | Randox Microalbumin Control Level 1 and Control Level 2 (Liquid)JJX · Traditional | Randox Laboratories, Ltd. | 07/11/2012SE |
| K121588 | Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3JJX · Traditional | Randox Laboratories, Ltd. | 06/20/2012SE |
| K121534 | Cone-Trol Hemoglobin A1C Control SetJJX · Traditional | Cone Bioproducts | 06/20/2012SE |
| K121237 | Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG…JJX · Traditional | Cliniqa Corporation | 05/18/2012SE |
| K121279 | Elecsys LH Calcheck 5JJX · Traditional | Roche Diagnostics | 05/10/2012SE |
| K113177 | Complete D 25-OH Vitamin D ControlJJX · Traditional | Quantimetrix Corp. | 05/10/2012SE |
| K121084 | Loci Cardiac Troponin-I Control (Low), Lctni Con LJJX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 05/09/2012SE |
| K112653 | On Call Vivid Blood Glucose Monitoring SystemsJJX · Traditional | ACON Laboratories, Inc. | 04/09/2012SE |
| K111938 | Ids-Isys IGFBP-3 Control Set, Ids-Isys Human Growth Hormone (HGH) Calibration Verifiers…JJX · Abbreviated | Immunodiagnostic Systems , Ltd. | 02/14/2012SE |
| K112143 | Audit Microcv T-Uptake LinearityJJX · Traditional | Aalto Scientific, Ltd. | 01/31/2012SE |
| K113764 | Glucose Meter-Check Solution for InfopiaJJX · Traditional | Bionostics, Inc. | 01/30/2012SE |
| K113524 | Validate Vit D Calibration Verification/ Linearity Test KitJJX · Traditional | Maine Standards Co. | 01/27/2012SE |
| K112352 | Glucose Meter-Check Control for Nipro TrueresultJJX · Traditional | Bionostics, Inc. | 12/23/2011SE |
| K112603 | Access Hybritech P2PSA QC on the Access Immunoassay SystemsJJX · Abbreviated | Beckman Coulter, Inc. | 11/04/2011SE |
| K112528 | Elecsys T4 Calcheck 5JJX · Traditional | Roche Diagnostics Corporation | 10/18/2011SE |
| K110061 | CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics | 09/21/2011SE |
| K112356 | Glucose Meter-Check Control Solution for Agamatrix WavesenseJJX · Traditional | Bionostics, Inc. | 09/19/2011SE |
| K112113 | Elecsys Myoglobin Calcheck 5JJX · Traditional | Roche Diagnostics | 09/14/2011SE |
| K111650 | Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D…JJX · Abbreviated | Immunodiagnostic Systems , Ltd. | 09/06/2011SE |
| K112104 | Elecsys N-Mid Osteocalcin Calcheck 5JJX · Traditional | Roche Diagnostics | 08/25/2011SE |
| K111552 | Elecsys T3 Calcheck 5JJX · Traditional | Roche Diagnostics | 07/21/2011SE |
| K111349 | Elecsys SHBG Calcheck 5JJX · Traditional | Roche Diagnostics | 06/09/2011SE |
| K110641 | Fujirebio Diagnostics Vitamin D ControlJJX · Traditional | Fujirebio Diagnostics,Inc. | 05/27/2011SE |
| K110613 | Elecsys Prolactin II Calcheck 5JJX · Traditional | Roche Diagnostics | 05/12/2011SE |
| K103744 | Dropper A1C Diabetes ControlJJX · Traditional | Quantimetrix Corp. | 05/12/2011SE |
| K103683 | Immulite/Immulite 1000 Progesterone Calibration Verification (CVM)JJX · Abbreviated | Siemens Healthcare Diagnostics | 04/28/2011SE |
| K110436 | Fdi Glucose Control Solution for AvivaJJX · Traditional | Fujirebio Diagnostics,Inc. | 04/20/2011SE |
| K110412 | Ids-Isys Ifg-I Control SetJJX · Abbreviated | Immunodiagnostic Systems , Ltd. | 03/16/2011SE |
| K103553 | Lifescan Onetouch Select / Ultra / Vita Glucose Control SolutionJJX · Traditional | Bionostics, Inc. | 02/10/2011SE |
| K103450 | Fdi Glucose Control Solution for FreestyleJJX · Traditional | Fujirebio Diagnostics,Inc. | 01/25/2011SE |
| K103402 | Elecsys Dhea-S Calcheck 5JJX · Traditional | Roche Diagnostics | 01/07/2011SE |
| K101427 | Audit Microcv Hs-Crp Linearity SetJJX · Traditional | Aalto Scientific, Ltd. | 12/23/2010SE |
| K100715 | Audit Microcv Homocysteine Linearity Set, Model 704M-5JJX · Traditional | Aalto Scientific, Ltd. | 12/23/2010SE |
| K103099 | Precicontrol HBA1C Norm; Precicontrol HBA1C PathJJX · Traditional | Roche Diagnostics | 12/06/2010SE |
| K102904 | Enhanced Estradiol (EE2) Master Curve MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics | 11/23/2010SE |
| K103162 | Elecsys PTH Calcheck 5JJX · Traditional | Roche Diagnostics | 11/18/2010SE |
| K102086 | Elecsys Ca 125 II Calcheck 5JJX · Traditional | Roche Diagnostics | 11/01/2010SE |
| K102269 | Elecsys Ige Calcheck 5JJX · Traditional | Roche Diagnostics | 10/07/2010SE |
| K101856 | Elecsys Cea Calcheck 5JJX · Traditional | Roche Diagnostics | 10/05/2010SE |
| K101365 | Elecsys Ca 19-9 Calcheck 5JJX · Traditional | Roche Diagnostics Corp. | 10/05/2010SE |
| K102260 | Fdi Glucose Control SolutionsJJX · Traditional | Fujirebio Diagnostics,Inc. | 09/24/2010SE |
| K102267 | Elecsys Ferritin Calcheck 5JJX · Traditional | Roche Diagnostics | 09/10/2010SE |
| K102044 | Elecsys Digoxin Calcheck 5JJX · Traditional | Roche Diagnostics | 08/31/2010SE |
| K093724 | Fora Control Solution, Taidoc Control SolutionJJX · Traditional | Taidoc Technology Corporation | 07/29/2010SE |
| K101075 | Elecsys Insulin Calcheck 5JJX · Traditional | Roche Diagnostics Corp. | 06/11/2010SE |
| K100750 | Audit Microcv Aso Linearity Set, Model K721M-5JJX · Traditional | Aalto Scientific, Ltd. | 05/21/2010SE |
| K094031 | Elecsys Folate III Calcheck 5JJX · Traditional | Roche Diagnostics | 04/27/2010SE |
| K100810 | Elecsys C-Peptide Calcheck 5JJX · Traditional | Roche Diagnostics | 04/26/2010SE |
| K092911 | Smart HBA1C Assay Kit, Model DZ168B-POC, Smart HBA1C Assay Control Kit, Model…JJX · Traditional | Diazyme Laboratories | 04/26/2010SE |
| K093836 | Elecsys TSH Calcheck 5JJX · Traditional | Roche Diagnostics | 04/15/2010SE |
| K100747 | Contrex Plus Low Control SolutionJJX · Traditional | Apex BioTechnology Corp. | 04/14/2010SE |
| K100594 | Elecsys Troponin I Calcheck 5JJX · Traditional | Roche Diagnostics | 04/01/2010SE |
| K093582 | Elecsys Ck-Mb Calcheck 5JJX · Traditional | Roche Diagnostics | 03/29/2010SE |
| K092848 | Elecsys Troponin T Calcheck 5JJX · Traditional | Roche Diagnostics Corp. | 03/19/2010SE |
| K093700 | Elecsys HCG Stat Calcheck 5JJX · Traditional | Roche Diagnostics Corp. | 03/04/2010SE |
| K092169 | Elecsys Probnp II Calcheck 5JJX · Traditional | Roche Diagnostics | 12/16/2009SE |
| K093498 | Liaison N-Tact PTH Calibration Verifiers Model 310913JJX · Traditional | DiaSorin, Inc. | 12/14/2009SE |
| K092749 | Mas and Mini-Trol PTH ControlJJX · Traditional | Microgenics Corporation | 12/03/2009SE |
| K092993 | Advia Centaur Cyclosporine Master Curve MaterialJJX · Abbreviated | Siemens Healthcare Diagnostics | 11/20/2009SE |
| K092168 | Elecsys Hcg+B Calcheck 5JJX · Traditional | Roche Diagnostics | 11/16/2009SE |
| K092888 | Elecsys Toxo Igg Calcheck 5JJX · Traditional | Roche Diagnostics Corp. | 11/10/2009SE |
| K091914 | Omnis Health Embrace Glucose Control SolutionJJX · Traditional | Bionostics, Inc. | 11/06/2009SE |
| K092585 | Elecsys Rubella Igga Calcheck 5JJX · Traditional | Roche Diagnostics | 10/30/2009SE |
| K091601 | Elecys Anti-Ccp CalcheckJJX · Traditional | Roche Diagnostics Corp. | 09/25/2009SE |
| K090104 | Liaison 25 Oh Vitamin D Total Calibration Verifiers, Model: 310603JJX · Traditional | DiaSorin, Inc. | 09/09/2009SE |
| K092645 | Fdi Glucose Control Levels 1, 2 and 3JJX · Traditional | Fujirebio Diagnostics,Inc. | 09/05/2009SE |
| K091123 | Advia Centaur Dheas Master Curve MaterialsJJX · Abbreviated | Siemens Healthcare Diagnostics | 08/14/2009SE |
| K091460 | Abt Glucose Control Solution Level 1,2,3 Model, 2120083,2120086, 2120087JJX · Traditional | American Biological Technologies, Inc. | 08/06/2009SE |
| K090943 | Abt Glucose Control Solution, Model: 2120089JJX · Traditional | American Biological Technologies, Inc. | 05/27/2009SE |
| K090311 | Elecsys Rubella Igg CalcheckJJX · Traditional | Roche Diagnostics | 05/05/2009SE |
| K090854 | Abt Glucose Control Solution, Model 2120090JJX · Traditional | American Biological Technologies, Inc. | 04/16/2009SE |
| K083655 | Elecsys Toxo Igg CalcheckJJX · Traditional | Roche Diagnostics | 02/12/2009SE |
| K083549 | Abt Glucose Control SolutionJJX · Traditional | American Biological Technologies, Inc. | 12/22/2008SE |
| K081478 | RNA Medical Glucose and B-Ketone Calibration Verification ControlsJJX · Traditional | Bionostics, Inc. | 10/06/2008SE |
| K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002JJX · Traditional | Bionostics, Inc. | 09/18/2008SE |
| K080643 | Elecsys Anti-Tshr CalcheckJJX · Traditional | Roche Diagnostics | 08/22/2008SE |
| K081915 | FDTX Glucose Control SolutionJJX · Traditional | Fujirebio Diagnostics Texas, Inc. | 08/08/2008SE |
| K080273 | Ab-Trol and Private Label Glucose Control SolutionJJX · Traditional | Fujirebio Diagnostics Texas, Inc. | 08/08/2008SE |
| K081403 | Glucose Meter-Check Control Solution for Roche Accu-ChekJJX · Traditional | Bionostics, Inc. | 07/25/2008SE |
| K080147 | Elecsys Probnp II CalcheckJJX · Traditional | Roche Diagnostics Corp. | 02/27/2008SE |
| K071648 | Extendsure Lyophilized HBA1C Linearity ControlsJJX · Traditional | Canterbury Scientific , Ltd. | 08/22/2007SE |
| K071587 | Ischemia Albumin Cobalt Binding Test (Acb Test) AssayJJX · Special | Inverness Medical Innovations, Inc. | 07/30/2007SE |
| K070506 | SMS Multi Glucose Control, Model 2120049JJX · Traditional | Medical Specialties Supply Co., Inc. | 04/18/2007SE |
| K070649 | SMS Glucose Control, Model 2120061JJX · Traditional | Spectrum Medical Supply, Inc. | 04/12/2007SE |
| K062957 | Fastpack Total Psa Method Verification KitJJX · Abbreviated | Qualigen, Inc. | 04/02/2007SE |
| K063855 | Liberty Normal Glucose Control Solution, Model 2120045/ High Glucose Control Solution…JJX · Traditional | Liberty Healthcare Group, Inc. | 02/01/2007SE |
| K062972 | Precinorm Ck-Mb and Precipath Ck-Mb ControlsJJX · Special | Roche Diagnostics Corp. | 10/13/2006SE |
| K062501 | Validate Thyroid Calibration Verification / Linearity Test Set, Model 901JJX · Traditional | Maine Standards Co. | 09/29/2006SE |
| K060510 | Drew Scientific Glycated Hemoglobin Five Level Linearity KitJJX · Traditional | Drew Scientific , Ltd. | 06/19/2006SE |
| K060706 | Liberty Normal Glucose Control SolutionJJX · Traditional | Liberty Healthcare Group, Inc. | 04/28/2006SE |
| K060570 | Hemoglobin Alc ControlJJX · Traditional | Compass Bioscience | 04/13/2006SE |
| K060215 | Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002JJX · Traditional | Eurotrol B.V. | 03/24/2006SE |
| K060481 | Liberty Glucose Control SolutionJJX · Traditional | Liberty Healthcare Group, Inc. | 03/09/2006SE |
| K060426 | Liberty Glucose Normal Control Solutions, Model 2120041JJX · Traditional | Liberty Healthcare Group, Inc. | 03/09/2006SE |
| K060133 | Ischemia Albumin Cobalt Binding Test (Acb) Assay Verification SetJJX · Traditional | Inverness Medical Innovations, Inc. | 02/16/2006SE |
| K060027 | Architect Dhea-S Calibrators (A-F) and Controls (Low, Medium and High)JJX · Traditional | Biokit, S.A. | 01/26/2006SE |
| K053327 | Oxicom ControlJJX · Traditional | Bionostics, Inc. | 01/26/2006SE |
| K052980 | Liberty Glucose Control, Model 2120031JJX · Traditional | Liberty Healthcare Group, Inc. | 11/30/2005SE |
| K053059 | Roche Diagnostics Elecsys Prolactin II CalcheckJJX · Special | Roche Diagnostics | 11/28/2005SE |
| K052679 | Cliniqa Liquid QC Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin…JJX · Traditional | Cliniqa Corporation | 11/18/2005SE |
| K052010 | HBA1C Linearity SetJJX · Traditional | Cone Bioproducts | 10/04/2005SE |
| K050983 | Irma Trupoint Creatinine Control KitJJX · Traditional | International Technidyne Corporation | 05/16/2005SE |
| K050961 | RNA1C Control for Nycocard HBA1CJJX · Traditional | Bionostics, Inc. | 05/13/2005SE |
| K050328 | Pregnancy-SkreenJJX · Traditional | Biochemical Diagnostic, Inc. | 03/29/2005SE |
| K050100 | RNA1C Hemoglobin A1C Control for Bayer DCA2000 and DCA2000+ AnalyzerJJX · Traditional | Bionostics, Inc. | 02/25/2005SE |
| K043584 | Liquichek BNP ControlJJX · Traditional | Bio-Rad Laboratories, Inc. | 02/08/2005SE |
| K043320 | Modification to Roche Elecsys Folate II Calcheck IIJJX · Special | Roche Diagnostics Corp. | 12/17/2004SE |
| K043070 | Liquid Stable HBA1C ControlJJX · Traditional | Canterbury Scientific , Ltd. | 12/09/2004SE |
| K042717 | Mas, Dade and Liquid Assayed Diabetes ControlJJX · Traditional | Medical Analysis Systems, Inc. | 11/05/2004SE |
| K042837 | Liquichek Elevated CRP ControlJJX · Traditional | Bio-Rad | 11/02/2004SE |
| K042448 | Diazyme Homocysteine Enzymatic Assay KitJJX · Traditional | General Atomics | 10/29/2004SE |
| K042303 | Vitros Immunodiagnostic Products Anti-Hbs ControlsJJX · Traditional | Ortho-Clinical Diagnostics | 09/27/2004SE |
| K042080 | Trackease Smart System Blood Glucose SystemJJX · Special | Home Diagnostics, Inc. | 08/19/2004SE |
| K041687 | Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (Assayed)…JJX · Abbreviated | Abbott Laboratories | 08/18/2004SE |
| K041898 | Cliniqa Liquid QC TDM Controls Levels 1,2 & 3/CLINIQA Linical TDM Calibration Verifiers…JJX · Traditional | Cliniqa Corporation | 08/16/2004SE |
| K041871 | Interlab Microcal Serum ControlsJJX · Traditional | Trouble Shooter Consuling, Inc. | 08/16/2004SE |
| K041194 | Abbott Architect Stat Troponin I Liquid Assayed Cardiac Marker Control Level L, M and HJJX · Traditional | Medical Analysis Systems, Inc. | 08/16/2004SE |
| K040927 | Linical Protein 1 Calibration Verifiers Levels a - E for Olympus Au AnalyzersJJX · Traditional | Cliniqa Corporation | 05/17/2004SE |
| K040918 | Wako Lipid Control, Level 1 and Level 2JJX · Traditional | Wako Chemicals USA, Inc. | 05/17/2004SE |
| K041016 | Nova Glucose Low/High Level Control SolutionsJJX · Traditional | Nova Biomedical Corp. | 05/07/2004SE |
| K040351 | Randox Liquid CRP ControlsJJX · Traditional | Randox Laboratories, Ltd. | 03/12/2004SE |
| K034048 | R&D Glu-Line Hematology ControlJJX · Traditional | R&D Systems, Inc. | 03/10/2004SE |
| K040455 | Linical Uric Acid Calibration Verifiers Levels a - E for Olympus Au SystemsJJX · Traditional | Cliniqa Corporation | 03/05/2004SE |
| K040025 | A1C-CELLULARJJX · Traditional | Streck Laboratories, Inc. | 03/02/2004SE |
| K040157 | Elecsys C-Peptide CalcheckJJX · Traditional | Roche Diagnostics Corp. | 02/25/2004SE |
| K030849 | Amnisure Fetal Membranes Rupture Test Model FMRT1JJX · Traditional | N-Dia, Inc. | 02/02/2004SE |
| K033433 | Nova Glucose Control SolutionsJJX · Traditional | Nova Biomedical Corp. | 01/02/2004SE |
| K033127 | Vitros Immunodiagnostic Products Anti-Hbc ControlsJJX · Traditional | Ortho-Clinical Diagnostics | 10/31/2003SE |
| K032993 | Vitros Immunodiagnostic Products Anti-Hbc Igm ControlsJJX · Traditional | Ortho-Clinical Diagnostics, Inc. | 10/31/2003SE |
| K032819 | Glucose Control Solution for Chdiagnostics Senova, Chdignostics Senova Blood Glucose…JJX · Traditional | Bionostics, Inc. | 10/20/2003SE |
| K031873 | I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration…JJX · Traditional | I-Stat Corporation | 10/07/2003SE |
| K031990 | Elecsys Precicontrol Troponin TJJX · Traditional | Roche Diagnostics Corp. | 08/20/2003SE |
| K031698 | Elecys SHBG CalcheckJJX · Traditional | Roche Diagnostics Corp. | 08/20/2003SE |
| K031890 | Mas Bilirubin Liquid Assayed Bilirubin ControlJJX · Traditional | Medical Analysis Systems, Inc. | 07/16/2003SE |
| K030628 | SAS RSV Control KitJJX · Traditional | Sa Scientific, Inc. | 03/17/2003SE |
| K030065 | Wako Nefa Linearity SetJJX · Traditional | Wako Chemicals USA, Inc. | 02/11/2003SE |
| K020883 | Elecsys Probnp CalcheckJJX · Traditional | Roche Diagnostics Corp. | 11/29/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1855-2025 Class II | HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.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-1854-2025 Class II | SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.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-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… | Ortho-Clinical Diagnostics, Inc. | 05/08/2024Open, Classified |
| Z-1312-2024 Class II | Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult"…Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures… | Mckesson Medical-Surgical Inc. Corporate… | 01/09/2024Open, 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). | Ortho-Clinical Diagnostics, Inc. | 05/18/2023Open, Classified |
| Z-1154-2023 Class II | ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative…Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used… | Siemens Healthcare Diagnostics, Inc. | 01/09/2023Open, Classified |
| Z-1153-2023 Class II | ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative…Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used… | Siemens Healthcare Diagnostics, Inc. | 01/09/2023Open, Classified |
| Z-1152-2023 Class II | ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative…Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used… | Siemens Healthcare Diagnostics, Inc. | 01/09/2023Open, 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… | Ortho-Clinical Diagnostics, Inc. | 10/15/2021Terminated |
| Z-2012-2021 Class III | ACE Control Set - IVD Control set for the quantitative determination of Angiotensin…Claim for stability after reconstitution from lyophilized to liquid form does not meet the requirements. New… | Sentinel CH SpA | 04/30/2021Open, Classified |
| Z-1135-2021 Class III | S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the…Medline Industries, Inc. is removing specific lots of STAT-Site Controls (Low and High) S-O303000, from the… | Medline Industries Inc | 01/15/2021Terminated |
| Z-2968-2020 Class II | Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for…Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting… | Tosoh Bioscience Inc | 08/07/2020Terminated |
| Z-1894-2020 Class III | ARCHITECT C Peptide Calibrator - 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-2079-2019 Class III | ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation…Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP… | Abbott Laboratories | 05/24/2019Terminated |
| Z-1357-2019 Class III | ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1018-2019 Class II | Fructosamine Control 3, FR2996 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-1017-2019 Class II | Fructosamine Control 1, FR2994 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-1256-2017 Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2…Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator… | Siemens Healthcare Diagnostics, Inc | 01/10/2017Terminated |
| Z-1255-2017 Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2…Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator… | Siemens Healthcare Diagnostics, Inc | 01/10/2017Terminated |
| Z-1254-2017 Class II | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2…Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator… | Siemens Healthcare Diagnostics, Inc | 01/10/2017Terminated |
| Z-0529-2019 Class III | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme…Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12%… | Helena Laboratories, Inc. | 11/07/2016Terminated |
| Z-0408-2017 Class II | Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is…Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their… | Beckman Coulter Inc. | 10/24/2016Terminated |
| Z-0328-2016 Class III | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage -…CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared… | Biochemical Diagnostics Inc | 09/14/2015Terminated |
| Z-2482-2015 Class II | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality…If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher… | Bayer Healthcare, LLC | 06/22/2015Terminated |
| Z-1840-2015 Class III | The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The…The spare component Anti-HBs Cutoff Calibrator, Catalog number 26154, is recalled because the expiration… | Bio-Rad Laboratories, Inc. | 05/13/2015Terminated |
| Z-0135-2015 Class II | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6…HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot.… | Abbott Laboratories | 04/30/2014Terminated |
| Z-1672-2014 Class II | ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic…Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to… | Abbott Laboratories | 02/12/2014Terminated |
| Z-1563-2013 Class II | Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is…It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed… | Microgenics Corporation | 05/13/2013Terminated |
| Z-1130-2013 Class II | LifeScan brand OneTouch Select Control Solution, Part Number/Model #: 02168902. Testing…When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the… | Lifescan Inc | 02/25/2013Terminated |
| Z-1129-2013 Class II | LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808…When OneTouch Ultra and OneTouch Select test strips are tested with Ultra and Select control solution the… | Lifescan Inc | 02/25/2013Terminated |
| Z-1239-2012 | Access Ostase QC, Part Number: 37309. The Access Ostase QC is intended for monitoring…The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet… | Beckman Coulter Inc. | 11/10/2011Terminated |
| Z-2606-2011 | Access Immunoassay Systems Quality Control Kits, Part Number: 37309 The Access Ostase QC…The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials… | Beckman Coulter Inc. | 05/10/2011Terminated |
| Z-1864-2011 | Cardiac Marker Control Calibration Verification Set, List number 136604/06F15-02. Used…Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker… | Abbott Point Of Care Inc. | 12/17/2010Terminated |
| Z-1863-2011 | Cardiac Marker Control Level 1, List Number 136601-06F12-02; Cardiac Marker Control…Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker… | Abbott Point Of Care Inc. | 12/17/2010Terminated |
| Z-2208-2010 | Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for…The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219)… | Beckman Coulter Inc. | 04/21/2010Terminated |
| Z-0216-2009 | Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL…The values listed in the Architect LH MasterCheck, Lot 82520 data sheet are incorrect. When MasterChecks do… | Abbott Laboratories | 09/05/2008Terminated |
| Z-1570-2008 | Architect Total T4 MasterCheck; a single (specified) analyte control (assayed and…Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4… | Abbott Laboratories | 02/27/2008Terminated |
| Z-1569-2008 | Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and…Testing material becomes unstable at the recommeded storage temperature. Some of the Architect Free T4… | Abbott Laboratories | 02/27/2008Terminated |
| Z-0120-2008 | AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model:…Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes… | AmniSure International LLC | 10/03/2007Terminated |
| Z-1222-2007 | ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL…The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8… | Abbott Laboratories | 07/06/2007Terminated |
| Z-0007-2008 | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of…Firm discovered that a deterioration value of approximately 20% was found when the product of this lot was… | Tosoh Bioscience Inc | 06/22/2007Terminated |