Calibrator, Multi-Analyte Mixture
FDA product code JIX · Class II (moderate risk) · 21 CFR 862.1150 · Clinical Chemistry
302510(k) clearances
0PMA approvals
62recalls
Manufacturers
- Alko Diagnostic Corp. 21
- Dade Behring, Inc. 18
- Roche Diagnostics Corp. 14
- Siemens Healthcare Diagnostics, Inc. 12
- Bhp Diagnostix, Inc. 11
- Roche Diagnostic Systems, Inc. 9
- Beckman Instruments, Inc. 8
- Boehringer Mannheim Corp. 8
- Shaban Mfg. Co. 7
- Gilford Diagnostics 7
- Verichem Laboratories, Inc. 6
- Bayer Healthcare, LLC 6
- Phoenix Diagnostics, Inc. 5
- Kmn Products, Inc. 5
- E.I. Dupont DE Nemours & Co., Inc. 5
- Randox Laboratories, Ltd. 5
- Biotrol, USA, Inc. 5
- Casco Standards 4
- Instrumentation Laboratory CO 4
- Baxter Healthcare Corp 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3JIX · Abbreviated | Ortho-Clinical Diagnostics, Inc. | 05/20/2016SE |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/18/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | Elitechgroup | 07/08/2015SE |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…JIX · Traditional | Siemens Healthcare Diagnostics | 06/15/2015SE |
| K141388 | System CalibraterJIX · Abbreviated | Beckman Coulter Ireland, Inc. | 07/11/2014SE |
| K133330 | C.F.A.S. Proteins, C.F.A.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…JIX · Special | Roche Diagnostics | 11/26/2013SE |
| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | Elitechgroup | 04/04/2013SE |
| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
| K122398 | Rapidpoint 500 System Measurement Cartridge with CalibratorsJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/12/2012SE |
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | Verichem Laboratories, Inc. | 03/28/2012SE |
| K112029 | Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | Elitechgroup | 08/30/2011SE |
| K110394 | Atac Serum Calibrator (Direct Bilirubin and Iron)JIX · Abbreviated | Vital Diagnostics (Manufacturing) Ptyltd | 06/09/2011SE |
| K110251 | Synchron Multi CalibratorJIX · Traditional | Beckman Coulter, Inc. | 05/25/2011SE |
| K103701 | Advia Chemistry Liquid Specific Protein CalibratorsJIX · Abbreviated | Siemens Healthcare Diagnostics, Inc. | 02/18/2011SE |
| K103171 | Elecsys Anti-Tpo CalsetJIX · Traditional | Roche Diagnostics | 02/11/2011SE |
| K103403 | Multiconstituent CalibratorJIX · Traditional | Abbott Laboratories | 02/04/2011SE |
| K103612 | Dimension Visa Enz 2 CalJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/25/2011SE |
| K101456 | Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator…JIX · Special | Roche Diagnostics | 09/08/2010SE |
| K101460 | Loci 8 Calibrator, Model KC 646JIX · Abbreviated | Siemens Healthcare Diagnostics | 07/09/2010SE |
| K100778 | Dimension Exl Loci Thyroid Calibrator, Model RC 610AJIX · Traditional | Siemens Healthcare Diagnostics | 05/05/2010SE |
| K093732 | Advia Chemistry Drug Calibrator I Model 10376770JIX · Abbreviated | Siemens Healthcare Diagnostics | 03/22/2010SE |
| K093645 | Exl Anem Cal, Model RC640JIX · Traditional | Siemens Healthcare Diagnostics | 03/05/2010SE |
| K092113 | Sta - Free PS CalibratorJIX · Traditional | Diagnostica Stago, Inc. | 11/13/2009SE |
| K090283 | Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3JIX · Abbreviated | Genchem, Inc. | 06/05/2009SE |
| K080404 | Easyqc - Chemistry with Electrolytes; Chemistry; Electrolytes Kit; Chemistry Calibrator…JIX · Traditional | Medica Corp. | 03/13/2009SE |
| K083579 | Dimension Vista System Enzyme 6 Calibrator, Model KC360JIX · Abbreviated | Siemens Healthcare Diagnostics | 02/20/2009SE |
| K081533 | Sentinel Plasmaproteins Cal 3XJIX · Traditional | SENTINEL CH. SpA | 06/25/2008SE |
| K081103 | Loci Thyroid Calibrator with Model RC610JIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/23/2008SE |
| K073612 | Uric Acid (Aox), Scal, Nortrol, AbtrolJIX · Traditional | Thermofisher Scientific OY | 05/23/2008SE |
| K080607 | Calibrator for Automated Systems (C.F.A.S.) Proteins with Model 11355279160JIX · Traditional | Roche Diagnostics Corp. | 05/12/2008SE |
| K071779 | Abx Pentra Urine CalJIX · Abbreviated | Horiba Abx | 03/05/2008SE |
| K072435 | Dimension Vista Protein 3 Calibrator, 3 CONTROL,1 Control L, 1 Control M, 1 Control HJIX · Traditional | Dade Behring, Inc. | 10/17/2007SE |
| K072204 | Advia Chemistry Microalbumin Calibrators, _2 CalibratorsJIX · Abbreviated | Siemens Medical Solutions Diagnostics | 10/05/2007SE |
| K071801 | Vitros Chemistry Products Ci-Slides, Calibrator Kit 2, Model(S) 844-5207, 166-2659JIX · Special | Ortho-Clinical Diagnostics, Inc. | 07/20/2007SE |
| K070971 | Modification to Sentinel Clin Chem CalJIX · Traditional | Sentinel Ch. Srl | 05/23/2007SE |
| K070207 | Multi-Analyte Chemistry CalibratorJIX · Abbreviated | Pointe Scientific, Inc., | 04/13/2007SE |
| K063508 | Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…JIX · Traditional | Dade Behring, Inc. | 01/23/2007SE |
| K062035 | Dimension Vista RF Flex Reagent Cartridge; Protein 2 Calibrator and ControlJIX · Traditional | Dade Behring, Inc. | 10/04/2006SE |
| K062334 | Dimension Vista Chemistry 3 Calibrator, Model KC130JIX · Traditional | Dade Behring, Inc. | 09/22/2006SE |
| K062319 | Calibrator for Automated Systems (C.F.A.S.), Model 10759350 360JIX · Traditional | Roche Diagnostics Corp. | 09/13/2006SE |
| K062034 | Dimension Vista System Drug 1 Calibrator (Drug 1 Cal - KC410)JIX · Traditional | Dade Behring, Inc. | 09/06/2006SE |
| K062122 | Dimension Vista System Chemistry 3 Calibrator (Chem 3 Cal - KC130)JIX · Traditional | Dade Behring, Inc. | 08/25/2006SE |
| K061923 | Dimension Vista Enzyme 1 Calibrator (Enz 1 Cal - KC310)JIX · Traditional | Dade Behring, Inc. | 08/25/2006SE |
| K061838 | Dimension Vista Chemistry 1 Calibrator, Model KC110JIX · Traditional | Dade Behring, Inc. | 08/21/2006SE |
| K061750 | Dimension Vista System Lipid Calibrator, Model KC220JIX · Traditional | Dade Behring, Inc. | 08/11/2006SE |
| K062055 | Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighJIX · Traditional | Dade Behring, Inc. | 08/07/2006SE |
| K061703 | Dimension Vista Chemistry 2 Calibrator (Chem 2 Cal, KC120)JIX · Traditional | Dade Behring, Inc. | 08/02/2006SE |
| K061056 | Randox Liquid Protein CalibratorJIX · Traditional | Randox Laboratories, Ltd. | 07/20/2006SE |
| K061390 | Dimension Vista System ENZYME2 Calibrator, Model KC320JIX · Traditional | Dade Behring, Inc. | 07/05/2006SE |
| K061218 | Dimension Vista System Chemistry Calibrator 4, Model KC140JIX · Traditional | Dade Behring, Inc. | 06/30/2006SE |
| K060940 | Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/Hpt…JIX · Traditional | Ortho-Clinical Diagnostics, Inc. | 04/24/2006SE |
| K053153 | Randox Calibration SerumJIX · Traditional | Randox Laboratories, Ltd. | 01/13/2006SE |
| K051452 | Sentinel Clin Chem CalJIX · Abbreviated | Sentinel Ch. Srl | 10/25/2005SE |
| K051619 | Lipoprotein for Multiple AnalytesJIX · Abbreviated | Bayer Healthcare, LLC | 08/01/2005SE |
| K051457 | Sentinel Plasmaproteins Cal 3XJIX · Abbreviated | Sentinel Ch. Srl | 07/25/2005SE |
| K050026 | Precinorm Proteins in Urine/Csf (Puc) and Precipath PucJIX · Special | Roche Diagnostics | 01/31/2005SE |
| K043460 | Olympus Lyophilized Chemistry Calibrators DR0070 and DR0071JIX · Abbreviated | Olympus America, Inc. | 01/31/2005SE |
| K041926 | Hdl/Ldl-Advance Calibrator, Cat. No. SE-278JIX · Traditional | Diagnostic Chemicals , Ltd. | 11/23/2004SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | Wako Chemicals USA, Inc. | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | Wako Chemicals USA, Inc. | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | Wako Chemicals USA, Inc. | 11/08/2004SE |
| K042243 | Microalbumin Multi-Calibrator SetJIX · Traditional | Diagnostic Chemicals , Ltd. | 10/04/2004SE |
| K041905 | Hemosil Calibration PlasmaJIX · Traditional | Instrumentation Laboratory CO | 09/28/2004SE |
| K041870 | N Apolipoprotein Standard SerumJIX · Traditional | Dade Behring, Inc. | 07/27/2004SE |
| K040264 | Calibrator for Automated Systems Proteins in Urine/CsfJIX · Traditional | Roche Diagnostics Corp. | 04/02/2004SE |
| K040245 | Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.F.A.S. Pac)JIX · Traditional | Roche Diagnostics Corp. | 03/24/2004SE |
| K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct Hdl/Ldl Cholesterol CalibratorJIX · Traditional | Stanbio Laboratory | 03/12/2004SE |
| K033873 | Elecsys C-Peptide CalsetJIX · Traditional | Roche Diagnostics Corp. | 02/13/2004SE |
| K033791 | Bayer Specific Protein Reference SerumJIX · Abbreviated | Bayer Healthcare, LLC | 02/13/2004SE |
| K033910 | Olympus Urine CalibratorJIX · Traditional | Cliniqa Corporation | 01/30/2004SE |
| K033380 | Bayer Special Chemistry CalibratorsJIX · Abbreviated | Bayer Diagnostics Corp. | 12/16/2003SE |
| K032665 | Olympus Lyophilized Calibrator, Models DR0070 and DR0071JIX · Abbreviated | Olympus America, Inc. | 11/21/2003SE |
| K033501 | Modification to Calibrator for Automatic Systems (Cfas)JIX · Special | Roche Diagnostics Corp. | 11/20/2003SE |
| K033061 | Calibrating Material, Ise Electrolyte ReferenceJIX · Traditional | Diamond Diagnostics, Inc. | 11/07/2003SE |
| K032287 | Modification to Synchron Systems Enzyme Validator Set Levels 1 and 2JIX · Special | Beckman Coulter, Inc. | 08/18/2003SE |
| K031608 | Randox Liquid Protein CalibratorJIX · Traditional | Randox Laboratories, Ltd. | 08/08/2003SE |
| K031683 | Tox Ammonia CalibratorJIX · Abbreviated | Bayer Healthcare, LLC | 08/06/2003SE |
| K031880 | AMMONIA/ETHANOL/CO2 Calibrator, Control Normal, Control AbnormalJIX · Special | Roche Diagnostics Corp. | 07/16/2003SE |
| K031682 | Lipoprotein CalibratorJIX · Abbreviated | Bayer Healthcare, LLC | 06/25/2003SE |
| K030804 | Bayer Advia 1650 Special Chemistry CalibratorJIX · Abbreviated | Bayer Healthcare, LLC | 04/10/2003SE |
| K030621 | Atac CalibratorJIX · Traditional | Elan Diagnostics | 03/19/2003SE |
| K024305 | Wiener Lab. Calibrator a Plus, Model 2X3 ML Cat. Nr. 1918006JIX · Traditional | Wiener Laboratories Saic | 03/18/2003SE |
| K030169 | Setpoint Chemistry CalibratorJIX · Abbreviated | Bayer Healthcare, LLC | 01/31/2003SE |
| K023792 | Calibration Pack, Models A9100-101S and A9100-103SJIX · Traditional | Thermo Orion | 01/31/2003SE |
| K030074 | Linical Immunology Calibration Verifiers Levels A-E for Beckman Coulter Synchron CX…JIX · Traditional | Cliniqa Corporation | 01/21/2003SE |
| K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1JIX · Special | Ortho-Clinical Diagnostics, Inc. | 12/10/2002SE |
| K023268 | Phoenix Ise Standard A,B and C for Roche/Avl SystemsJIX · Traditional | Phoenix Diagnostics, Inc. | 11/15/2002SE |
| K023158 | Randox Apolipoprotein CalibratorJIX · Traditional | Randox Laboratories, Ltd. | 10/24/2002SE |
| K022767 | Raichem Lipid CalibratorJIX · Special | Hemagen Diagnostics, Inc. | 09/03/2002SE |
| K022108 | Thermo Dma Data-Cal Calibrator, Model 1905-050JIX · Traditional | Thermo Dma, Inc. | 07/25/2002SE |
| K013397 | Pacific Hemostasis Reference EmulsionJIX · Traditional | Fisher Diagnostics | 02/15/2002SE |
| K020129 | Phoenix Eletrolyte Calibration Set for the Roche Cobas Ise ModuleJIX · Traditional | Phoenix Diagnostics, Inc. | 02/01/2002SE |
| K013178 | DC-UIBC-CO2-CAL, Model SE-153JIX · Traditional | Diagnostic Chemicals , Ltd. | 12/18/2001SE |
| K012987 | Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium AnalyzerJIX · Traditional | Phoenix Diagnostics, Inc. | 11/07/2001SE |
| K012509 | Phoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension Chemistry…JIX · Traditional | Phoenix Diagnostics, Inc. | 10/09/2001SE |
| K012470 | Modification to N Protein Standard SLJIX · Traditional | Dade Behring, Inc. | 09/28/2001SE |
| K012250 | Raichem Multi-Analyte CalibratorJIX · Abbreviated | Hemagen Diagnostics, Inc. | 09/24/2001SE |
| K011658 | Calibrator for Automated Systems (C.F.A.S.) LipidsJIX · Abbreviated | Rochdiag | 07/31/2001SE |
| K011226 | Calibrator for Automated SystemsJIX · Abbreviated | Roche Diagnostics Corp. | 06/25/2001SE |
| K011035 | Dimension Drug Calibrator, Model DC22BJIX · Traditional | Dade Behring, Inc. | 06/14/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | Sigma Diagnostics, Inc. | 03/30/2001SE |
| K010030 | Liquispx Hdl/Ldl Liquid Cholesterol CalibratorJIX · Traditional | Synergent Biochem Inc.-Clinical Controls Div. | 02/14/2001SE |
| K002804 | N Protein Standard SLJIX · Traditional | Dade Behring, Inc. | 10/05/2000SE |
| K001484 | Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse…JIX · Traditional | Alko Diagnostic Corp. | 06/19/2000SE |
| K000576 | Elecsys Cortisol CalcheckJIX · Traditional | Roche Diagnostics Corp. | 03/21/2000SE |
| K993853 | K-Assay Multi-Analyte CalibratorJIX · Traditional | Kamiya Biomedical Co. | 12/27/1999SE |
| K993606 | K-Assay Apo A1/B Calibrator SetJIX · Traditional | Kamiya Biomedical Co. | 11/26/1999SE |
| K992845 | Hichem Calibrator 1 Kit, Hichem Calibrator 2 Kit, Hichem Calibrator 3 Kit, Calibration…JIX · Traditional | Elan Holdings, Inc. | 10/18/1999SE |
| K993098 | Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional | Data Medical Associates, Inc. | 10/08/1999SE |
| K992086 | Olympus Serum Protein Multicalibrator 2JIX · Traditional | Olympus America, Inc. | 08/19/1999SE |
| K991166 | K-Assay Microalbumin Calibrator SetJIX · Traditional | Kamiya Biomedical Co. | 06/10/1999SE |
| K991181 | Modification of N Protein Standard SLJIX · Traditional | Dade Behring, Inc. | 06/01/1999SE |
| K990460 | Calibrator for Automated Systems (C.F.A.S.)JIX · Traditional | Roche Diagnostics Corp. | 03/22/1999SE |
| K984425 | Modification of Preciset Serum Proteins CalibratorJIX · Traditional | Boehringer Mannheim Corp. | 01/20/1999SE |
| K984014 | Synchron Systems Enzyme Validator Set Levels 1 and 2JIX · Traditional | Beckman Coulter, Inc. | 12/23/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | Boehringer Mannheim Corp. | 11/25/1998SE |
| K982767 | Raichem Hdl-Cholesterol Direct Reagent, Hdl-Cholesterol CalibratorJIX · Traditional | Raichem | 09/21/1998SE |
| K982501 | Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent…JIX · Traditional | Alko Diagnostic Corp. | 09/01/1998SE |
| K981706 | Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, Upro Cal, and Ise…JIX · Traditional | Abbott Laboratories | 07/09/1998SE |
| K981795 | Cleaning Solution (1) Model Number A943-795, Salt Bridge Solution Model Number A943-794…JIX · Traditional | Thermo Bioanalysis Corp. | 06/12/1998SE |
| K981305 | Olympus Serum Protein MulticalibratorJIX · Traditional | Olympus America, Inc. | 05/07/1998SE |
| K981436 | Document Ammonia/Ethanol/Lactate Calibrator, PN: M-109JIX · Special | Casco Standards | 04/24/1998SE |
| K974825 | Boehringer Mannheim C.F.A.S. - Hdl/Ldl-C-PlusJIX · Traditional | Boehringer Mannheim Corp. | 01/30/1998SE |
| K974290 | Microprotein Standard KitJIX · Traditional | Verichem Laboratories, Inc. | 12/19/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | Beckman Instruments, Inc. | 12/15/1997SE |
| K973928 | Beckman Urine Protein Calibrator (Ucal)JIX · Traditional | Beckman Instruments, Inc. | 12/01/1997SE |
| K973345 | Matrix Plus Multi-Calibrator KitJIX · Traditional | Verichem Laboratories, Inc. | 10/29/1997SE |
| K972333 | Ammonia/Iron Standard KitJIX · Traditional | Verichem Laboratories, Inc. | 07/23/1997SE |
| K971283 | Synchron Systems Cal 5 PlusJIX · Traditional | Beckman Instruments, Inc. | 06/03/1997SE |
| K971333 | Synchron Systems Alkaline Phosphatase Reagent, Cholinesterase Reagent, Gamma-Glutamyl…JIX · Traditional | Beckman Instruments, Inc. | 05/23/1997SE |
| K970921 | Standard a Multiply (A540-0), Standard B Multiply (A550-0), Standard C Multiply (A560-0)JIX · Traditional | Alko Diagnostic Corp. | 04/08/1997SE |
| K964527 | N Rheumatology Standard SLJIX · Traditional | Behring Diagnostics, Inc. | 01/15/1997SE |
| K964829 | Elecsys Calcheck FSHJIX · Traditional | Boehringer Mannheim Corp. | 12/16/1996SE |
| K964062 | N Protein Strandard SLJIX · Traditional | Behring Diagnostics, Inc. | 11/21/1996SE |
| K963543 | Sigma Diagnostics CX -3 Calibration Standard, Level 2JIX · Traditional | Sigma Diagnostics, Inc. | 10/30/1996SE |
| K963533 | Sigma Diagnostic CX -3 Calibration Standard Level 1JIX · Traditional | Sigma Diagnostics, Inc. | 10/29/1996SE |
| K962269 | Cedia Cardiac TDM Multi-CalsJIX · Traditional | Boehringer Mannheim Corp. | 10/29/1996SE |
| K962629 | Document Ammonia, Ethanol, Lactate CalibratorJIX · Traditional | Casco Standards | 09/13/1996SE |
| K962410 | N Protein Standard PyJIX · Traditional | Behring Diagnostics, Inc. | 07/16/1996SE |
| K962406 | N CRP Standard SyJIX · Traditional | Behring Diagnostics, Inc. | 07/16/1996SE |
| K955489 | Calibration Serum Level 1 & 2JIX · Traditional | Randox Laboratories, Ltd. | 06/21/1996SE |
| K961659 | Cedia Core TDM Multi-CalJIX · Traditional | Boehringer Mannheim Corp. | 06/13/1996SE |
| K960103 | Dade Moni-Trol Candidate Product CombinationsJIX · Traditional | Dade Intl., Inc. | 04/26/1996SE |
| K960085 | Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak SystemsJIX · Traditional | Alko Diagnostic Corp. | 03/11/1996SE |
| K955154 | Cal 1 & Cal 2 Solution, Flush Solution KitJIX · Traditional | Alko Diagnostic Corp. | 12/11/1995SE |
| K953979 | Apolipoprotein Calibrator (Apo-Cal)JIX · Traditional | Beckman Instruments, Inc. | 10/03/1995SE |
| K942706 | Roche Calibrator SerumJIX · Traditional | Roche Diagnostic Systems, Inc. | 09/20/1995SE |
| K952282 | Roche AMMONIA/ETHANOL/CO2 CalibratorJIX · Traditional | Roche Diagnostic Systems, Inc. | 09/15/1995SE |
| K953863 | Hichem Ise Standards Kit 70011JIX · Traditional | Hichem Diagnostics | 09/06/1995SE |
| K945966 | Alko Calibrators and Flush Solution for Il 1300 Series Ph/Blood Gas AnalyzersJIX · Traditional | Alko Diagnostic Corp. | 02/10/1995SE |
| K944922 | Alko Cal Packs for Corning 654 AnalyzersJIX · Traditional | Alko Diagnostic Corp. | 02/10/1995SE |
| K943012 | CalibratorJIX · Traditional | Prisma Systems | 11/28/1994SE |
| K944639 | Documentr Ammonia/EthanolcalibratorJIX · Traditional | Casco Standards | 11/15/1994SE |
| K940760 | Fluids Pack for Coring 238JIX · Traditional | Alko Diagnostic Corp. | 09/06/1994SE |
| K941219 | Dupont Aca Plus Fsh/Lh/Prolactin CalibratorJIX · Traditional | Dupont Medical Products | 08/09/1994SE |
| K942549 | Alko Fluids Packs for Nova 8 AnalyzersJIX · Traditional | Alko Diagnostic Corp. | 07/28/1994SE |
| K940571 | Synermedir Cal I and Synermed Ir Cal IIJIX · Traditional | Synermed, Inc. | 04/21/1994SE |
| K934607 | Alko Reagents for Baxter Paramax Chemistry SystemJIX · Traditional | Alko Diagnostic Corp. | 03/28/1994SE |
| K935543 | Aca Plus Ferritin CalibratorJIX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 03/22/1994SE |
| K933383 | Reagents for Hitachi IseJIX · Traditional | Alko Diagnostic Corp. | 03/09/1994SE |
| K935547 | Cal 1 and Cal 2 Standards/Standards for Il 501 Sodium/Potassium AnalyzerJIX · Traditional | Alko Diagnostic Corp. | 01/18/1994SE |
| K935018 | Reagents for Orion 1020, and Related AnalyzersJIX · Traditional | Alko Diagnostic Corp. | 01/18/1994SE |
| K930231 | Alko Calibration for Amdev Lytening SystemsJIX · Traditional | Alko Diagnostic Corp. | 01/13/1994SE |
| K930199 | Alko Fluids Packs for Nova AnalyzersJIX · Traditional | Alko Diagnostic Corp. | 01/13/1994SE |
| K925464 | Calibration Solutions for Use on Electrolyte InstrJIX · Traditional | Alko Diagnostic Corp. | 01/13/1994SE |
| K925385 | Reagents for Abbott Spectrum/Epx (Electro Calibra)JIX · Traditional | Alko Diagnostic Corp. | 01/13/1994SE |
| K932623 | Quantimetrix Blood Glucose ControlsJIX · Traditional | Quantimetrix Corp. | 12/09/1993SE |
| K934701 | Reagents for Cobas Ise ModuleJIX · Traditional | Alko Diagnostic Corp. | 12/02/1993SE |
| K934143 | N-Assay Tia Microalbumin Calibrator SetJIX · Traditional | Crestat Diagnostics, Inc. | 11/05/1993SE |
| K932768 | Cardio Rep CK Calibrators 1 & 2 Cat. No. 3322 & 3323JIX · Traditional | Helena Laboratories | 10/18/1993SE |
| K933955 | Dupont Standard C for the Dimension Clinical Chemistry SystemJIX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 10/13/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | Sigma Chemical Co. | 10/13/1993SE |
| K933702 | Sigma CX-3 Calibration Standard Level 1JIX · Traditional | Sigma Chemical Co. | 10/08/1993SE |
| K930104 | Ace Clinical Chemistry SystemJIX · Traditional | Schiapparelli Biosystems, Inc. | 08/23/1993SE |
| K925101 | Systemate Plus CalibratorJIX · Traditional | Em Diagnostic Systems, Inc. | 02/23/1993SE |
| K926518 | Ise Calibrator for Dupont DimensionJIX · Traditional | Alko Diagnostic Corp. | 01/28/1993SE |
| K922043 | Roche Calibrator SerumJIX · Traditional | Roche Diagnostic Systems, Inc. | 06/16/1992SE |
| K921678 | Ciba Corning Acs Folate ImmunoassayJIX · Traditional | Ciba Corning Diagnostics Corp. | 06/09/1992SE |
| K915797 | CalibratorJIX · Traditional | Alko Diagnostic Corp. | 01/30/1992SE |
| K914909 | Il Test(Tm) Calibration Set SPJIX · Traditional | Instrumentation Laboratory CO | 01/22/1992SE |
| K914917 | Du Pont Total Protein/Albumin CalibratorJIX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 12/13/1991SE |
| K914750 | Roche Cobas(R) Ammonia and Ethanol CalibratorJIX · Traditional | Roche Diagnostic Systems, Inc. | 11/22/1991SE |
| K910309 | Paramax(R) Electrolyte Calibrator 1&2/MODIFICATIONJIX · Traditional | Baxter Healthcare Corp | 03/29/1991SE |
| K904767 | Acs Cholestrerol/Triglyceride Liquid Linear CalibrJIX · Traditional | Analytical Control Systems, Inc. | 12/26/1990SE |
| K903913 | Paramax Urine/Csf Calibrator Level I and IIJIX · Traditional | Baxter Healthcare Corp | 09/27/1990SE |
| K903888 | Hi Chem Protein/Lipids LinearityJIX · Traditional | Hichem Diagnostics | 09/27/1990SE |
| K902675 | Multi Analyte Mixture, CalibratorsJIX · Traditional | Phoenix Diagnostics, Inc. | 07/31/1990SE |
| K897097 | Cobas Ready Calibrator KitJIX · Traditional | Roche Diagnostic Systems, Inc. | 06/26/1990SE |
| K897177 | Calibrators, Control Materials, Electrodes & TubeJIX · Traditional | Nova Biomedical Corp. | 03/27/1990SE |
| K897071 | Roche Standards for the Cobas Ise ModuleJIX · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1990SE |
| K895717 | Sodium and Potassium StandardJIX · Traditional | Data Medical Associates, Inc. | 01/11/1990SE |
| K895135 | Hi Chem Calibrator A+JIX · Traditional | Hichem Diagnostics | 10/23/1989SE |
| K890583 | Hi Chem Calibration Standards Levels 1 and 2JIX · Traditional | Hichem Diagnostics | 03/13/1989SE |
| K884693 | Universal(Tm) Ion Select Electrode StandardsJIX · Traditional | Biomedical Research & Development Laboratories… | 12/15/1988SE |
| K884227 | Calibrator Standard Kit for Astra SystemJIX · Traditional | A-Kem, Inc. | 12/09/1988SE |
| K875285 | Multi-Chemistry Linearity StandardJIX · Traditional | Verichem Laboratories, Inc. | 09/02/1988SE |
| K882258 | Dc-Liquical Catalogue #SE-030JIX · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 08/30/1988SE |
| K882116 | Total Protein/Albumin StandardJIX · Traditional | Verichem Laboratories, Inc. | 06/24/1988SE |
| K881258 | Paramax Alcohol and Ammonia Calibrator, I & IIJIX · Traditional | Baxter Healthcare Corp | 05/27/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2895-2026 Class II | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | Aniara Diagnostica LLC | 07/01/2026Open, Classified |
| Z-1840-2025 Class II | ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B 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-1759-2024 Class II | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized…Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 &… | Randox Laboratories Ltd. | 03/05/2024Open, Classified |
| Z-1328-2024 Class II | Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with…The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material… | Randox Laboratories Ltd. | 03/01/2024Open, Classified |
| Z-0753-2024 Class II | Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays…Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the… | Randox Laboratories Ltd. | 11/20/2023Open, Classified |
| Z-0752-2024 Class II | Calibration Serum Level 3 CAL2351CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments… | Randox Laboratories Ltd. | 11/20/2023Open, Classified |
| Z-0751-2024 Class II | Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530)…There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3… | Randox Laboratories Ltd. | 11/13/2023Open, Classified |
| Z-0609-2024 Class II | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro…RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+)… | Siemens Healthcare Diagnostics Inc | 10/26/2023Open, Classified |
| Z-0608-2024 Class II | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro…RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+)… | Siemens Healthcare Diagnostics Inc | 10/26/2023Open, Classified |
| Z-0607-2024 Class II | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro…RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+)… | Siemens Healthcare Diagnostics Inc | 10/26/2023Open, Classified |
| Z-0606-2024 Class II | RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro…RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+)… | Siemens Healthcare Diagnostics Inc | 10/26/2023Open, Classified |
| Z-2448-2023 Class II | Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the…As part of the firm's ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories… | Randox Laboratories Ltd. | 07/19/2023Open, Classified |
| Z-1563-2021 Class II | Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number:…Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay… | Randox Laboratories Ltd. | 03/29/2021Terminated |
| 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… | Ortho-Clinical Diagnostics, Inc. | 02/18/2021Terminated |
| Z-0536-2021 Class II | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is…Products do not meet stability criteria and may impact results. | Chromsystems Instruments & Chemicals GmbH | 11/02/2020Terminated |
| Z-0521-2021 Class II | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 -…Calibrator lots may not meet stability criteria and could result in increased results of patient samples for… | Chromsystems Instruments & Chemicals GmbH | 10/29/2020Completed |
| 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… | Ortho Clinical Diagnostics Inc | 12/16/2019Terminated |
| Z-1261-2020 Class II | Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For…Atellica CH: The Atellica CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro… | Siemens Healthcare Diagnostics, Inc. | 11/19/2019Terminated |
| Z-1260-2020 Class II | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator -…Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC)… | Siemens Healthcare Diagnostics, Inc. | 11/19/2019Terminated |
| Z-0283-2020 Class II | Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032…The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British… | Randox Laboratories Ltd. | 08/09/2019Terminated |
| Z-2490-2019 Class III | This is an in vitro diagnostic product intended for use as a calibration serum in…Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line… | Randox Laboratories Ltd. | 07/12/2019Terminated |
| 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 | Ortho Clinical Diagnostics | 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 | Ortho Clinical Diagnostics | 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 | Ortho Clinical Diagnostics | 07/08/2019Terminated |
| Z-0660-2019 Class II | SP CAL (LIQ), REF IT2692 This product is intended for in vitro diagnostic use with…Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and… | Randox Laboratories Ltd. | 11/19/2018Terminated |
| 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… | Ortho-Clinical Diagnostics | 07/11/2018Terminated |
| Z-2827-2018 Class III | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains…Distribution of unapproved product labeling | Tosoh Bioscience Inc | 06/05/2018Terminated |
| Z-1184-2018 Class II | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic…An increase in the number of failed calibration events or negative bias with Quality Control (QC) and… | Siemens Healthcare Diagnostics, Inc. | 11/09/2017Terminated |
| Z-0605-2018 Class II | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry…Unpaired lots of AU lyophilized chemistry calibrator level 1 and 2 have been distributed. Calibrator level 1… | Beckman Coulter Inc. | 08/24/2017Terminated |
| Z-3138-2017 Class II | K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle…The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and… | Kamiya Biomedical Company, LLC | 07/19/2017Terminated |
| Z-2730-2017 Class II | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the…The firm identified a negative shift of 5mmol/L for sodium recovery in Synchron Control Level 3 when… | Beckman Coulter Inc | 05/15/2017Terminated |
| Z-2591-2018 Class II | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level…ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part… | ELITech Clinical Systems SAS | 04/18/2017Terminated |
| Z-0652-2017 Class II | Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in…Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension… | Siemens Healthcare Diagnostics, Inc. | 09/15/2016Terminated |
| Z-1216-2017 Class III | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of 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-2725-2017 Class III | Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and…Lot was not functioning properly and not exhibiting the correct physical properties. | AMS Diagnostics, LLC | 02/29/2016Open, Classified |
| Z-1079-2016 Class II | Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog…ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Siemens Healthcare Diagnostics, Inc | 02/04/2016Terminated |
| Z-1078-2016 Class II | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number:…ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Siemens Healthcare Diagnostics, Inc | 02/04/2016Terminated |
| Z-1077-2016 Class II | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number:…ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay | Siemens Healthcare Diagnostics, Inc | 02/04/2016Terminated |
| Z-1321-2015 Class II | ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the…Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for… | Siemens Healthcare Diagnostics, Inc. | 01/19/2015Terminated |
| Z-0164-2015 Class II | Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack…Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and… | Siemens Healthcare Diagnostics, Inc | 09/26/2014Terminated |
| Z-2720-2014 Class II | Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic…Siemens Healthcare Diagnostics has received complaints for low recovery of Magnesium (MG) Quality Control… | Siemens Healthcare Diagnostics, Inc. | 08/18/2014Terminated |
| Z-2643-2014 Class II | ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems…The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c… | Siemens Healthcare Diagnostics | 08/06/2014Terminated |
| Z-2214-2014 Class II | VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169…Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit… | Ortho-Clinical Diagnostics | 07/15/2014Terminated |
| Z-1146-2014 Class II | ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and…HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the… | Horiba Instruments, Inc dba Horiba Medical | 01/20/2014Terminated |
| Z-1076-2014 Class II | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro…Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) and… | Siemens Healthcare Diagnostics, Inc. | 01/06/2014Terminated |
| Z-1088-2014 Class II | VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics…Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to… | Ortho-Clinical Diagnostics | 10/17/2013Terminated |
| Z-1337-2013 Class III | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical…Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees… | Ortho-Clinical Diagnostics | 04/03/2013Terminated |
| Z-1277-2012 | VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol]…Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that… | Ortho-Clinical Diagnostics | 02/02/2012Terminated |
| Z-0110-2013 Class III | Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The…The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems… | Beckman Coulter Inc. | 12/15/2011Terminated |
| Z-0917-2012 | VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD ---…Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results… | Ortho-Clinical Diagnostics | 10/13/2011Terminated |