Multi-Analyte Controls, All Kinds (Assayed)
FDA product code JJY · Class I (low risk) · 21 CFR 862.1660 · Clinical Chemistry
673510(k) clearances
0PMA approvals
90recalls
Manufacturers
- Bio-Rad 61
- Medical Analysis Systems, Inc. 31
- Bio-Rad Laboratories, Inc. 26
- Roche Diagnostics Corp. 22
- Cliniqa Corporation 22
- Aalto Scientific, Ltd. 19
- Maine Standards Co. 19
- Boehringer Mannheim Corp. 17
- Casco Standards 15
- Randox Laboratories, Ltd. 15
- Ortho Diagnostic Systems, Inc. 13
- Ciba Corning Diagnostics Corp. 13
- Helena Laboratories 11
- Beckman Instruments, Inc. 10
- Bionostics, Inc. 10
- Baxter Healthcare Corp 10
- Analytical Control Systems, Inc. 10
- American Dade 9
- Dade Behring, Inc. 8
- Creative Laboratory Products, Inc. 8
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
| K133676 | Abx Pentra Micro Alb Control L/HJJY · Abbreviated | Horiba Abx SAS | 07/11/2014SE |
| K141073 | Liquichek Tumor Marker ControlJJY · Traditional | Bio-Rad Laboratories | 06/23/2014SE |
| K140522 | Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium…JJY · Traditional | Randox Laboratories Limited | 05/22/2014SE |
| K140916 | Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/MinipakJJY · Traditional | Bio-Rad Laboratories | 05/06/2014SE |
| K140764 | Liquichek Immunologycontrol-Level 1,LEVEL 2, Level 3, MinipakJJY · Traditional | Bio-Rad Laboratories | 04/25/2014SE |
| K134013 | Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative…JJY · Traditional | Bio-Rad Laboratories | 04/24/2014SE |
| K140393 | Randox Ammonia Ethanol Control Levels 1, 2 and Level 3JJY · Traditional | Randox Laboratories Limited | 03/25/2014SE |
| K133960 | Lypochek Specialty Immunoassay ControlJJY · Traditional | Bio-Rad Laboratories | 01/22/2014SE |
| K132227 | Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium…JJY · Traditional | Bio-Rad Laboratories | 10/25/2013SE |
| K132156 | Randox CSF Controls Levels 2 and 3JJY · Traditional | Randox Laboratories, Ltd. | 10/23/2013SE |
| K132751 | Multichem S Plus / S Plus (Assayed)JJY · Abbreviated | Techno-Path Manufacturing , Ltd. | 10/22/2013SE |
| K131993 | Multichem UJJY · Abbreviated | Techno-Path Manufacturing , Ltd. | 10/15/2013SE |
| K131479 | V8 SP Normal Control, Abnormal ControlJJY · Traditional | Helena Laboratories | 10/07/2013SE |
| K131992 | Multichem PJJY · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/25/2013SE |
| K132091 | Multichem Ia and Ia PlusJJY · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
| K131595 | Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVMJJY · Traditional | Eurotrol B.V. | 07/26/2013SE |
| K130337 | Randox Speciality Control (I) Levels 1, 2 and 3JJY · Traditional | Randox Laboratories Limited | 06/19/2013SE |
| K130963 | Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2; Liquichek…JJY · Traditional | Bio-Rad Laboratories, Inc. | 05/06/2013SE |
| K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 04/29/2013SE |
| K124009 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Mission Clinicheck Assayed…JJY · Traditional | Diamond Diagnostics, Inc. | 04/17/2013SE |
| K130761 | Liquichek Immunology Control, Level 1,2,3, Trilevel MinipakJJY · Traditional | Bio-Rad Laboratories | 04/12/2013SE |
| K123725 | Fastpack Control KitJJY · Traditional | Qualigen, Inc. | 03/08/2013SE |
| K130162 | Liquid Assayed Multiqual PremiumJJY · Traditional | Bio-Rad Laboratories | 03/01/2013SE |
| K123775 | Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/31/2013SE |
| K123663 | Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakJJY · Traditional | Bio-Rad Laboratories | 12/27/2012SE |
| K123198 | Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control…JJY · Traditional | Bio-Rad Laboratories | 11/20/2012SE |
| K121603 | Randox Immunoassay Speciality Control (II), Level 1, Level 2 and Level 3JJY · Traditional | Randox Laboratories, Ltd. | 11/20/2012SE |
| K122838 | Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus…JJY · Traditional | Bio-Rad Laboratories | 10/17/2012SE |
| K113720 | Randox Maternal Control, Levels 1, 2 and 3JJY · Traditional | Randox Laboratories, Ltd. | 09/20/2012SE |
| K122291 | Thermo Scientific Mas Omni-CardioJJY · Traditional | Microgenics Corporation | 08/31/2012SE |
| K121759 | Cone-Trol Liquid Chemistry ControlsJJY · Abbreviated | Cone Bioproducts | 07/24/2012SE |
| K121794 | Liquichek Urine Chemistry ControlJJY · Traditional | Bio-Rad, Diagnostics Grp. | 07/11/2012SE |
| K121468 | Eurotrol Gas-Ise MetabolitesJJY · Traditional | Eurotrol B.V. | 06/22/2012SE |
| K112742 | Audit Microlq Spinal Fluid ControlJJY · Traditional | Aalto Scientific, Ltd. | 06/15/2012SE |
| K111964 | Audit Microcv Urine/Fluids Chemistry LinearityJJY · Traditional | Aalto Scientific, Ltd. | 03/02/2012SE |
| K112705 | Audit(R) Microlq(Tm) Serum Protein ControlJJY · Traditional | Aalto Scientific, Ltd. | 01/24/2012SE |
| K110534 | Randox Liquid Cardiac Control Levels 1, 2 and 3JJY · Traditional | Randox Laboratories Limited | 01/23/2012SE |
| K112337 | Randox Liquid Immunoassay Premium Controls, Level 1, LEVEL2, Level 3 and Tri LevelJJY · Traditional | Randox Laboratories, Ltd. | 12/01/2011SE |
| K101863 | It/If ControlJJY · Traditional | Sebia | 11/07/2011SE |
| K110738 | Thermo Scientific Mas Omni-CoreJJY · Traditional | Microgenics Corporation | 11/03/2011SE |
| K110904 | Randox Liquid Urine Control Levels 2 and 3JJY · Traditional | Randox Laboratories, Ltd. | 09/30/2011SE |
| K111996 | Elitech Clinical Sysems Ise Control 1 and 2JJY · Abbreviated | Elitechgroup | 09/14/2011SE |
| K111506 | Elecsys Precicontrol Varia 3JJY · Traditional | Roche Diagnostics | 07/08/2011SE |
| K110880 | Validate (R) GC3 Calibration Verification / Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 07/05/2011SE |
| K110616 | Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProJJY · Traditional | Microgenics Corp. | 06/29/2011SE |
| K111063 | Vital Serum ControlsJJY · Traditional | Vital Diagnostics (Manufacturing) Ptyltd | 06/28/2011SE |
| K103601 | Audit Microcv Immunoassay Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 06/10/2011SE |
| K103364 | Mission Clinicheck Assayed Chemistry Controls, Level 1, Level 2, Dual LevelJJY · Traditional | Diamond Diagnostics, Inc. | 05/06/2011SE |
| K103271 | MSC Lipid ControlJJY · Traditional | Maine Standards Co. | 01/25/2011SE |
| K101216 | Audit Microcv Protein Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 01/14/2011SE |
| K102617 | Audit Microcv Cardiac Markers Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 01/10/2011SE |
| K102700 | Lipid Controls; Multi- Analyte Control; Multi-Analyte Calibration Verification MaterialsJJY · Traditional | Alere, San Diego, Dba Biosite INcorporated, Dba IN | 12/21/2010SE |
| K101809 | Fujirebio Diagnostics Tumor Marker Control Model 108-20JJY · Traditional | Fujirebio Diagnostics,Inc. | 10/05/2010SE |
| K100727 | Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3…JJY · Traditional | Bio-Rad, Diagnostics Grp. | 09/14/2010SE |
| K100718 | Audit Microcv Ammonian/Ethanol Linearity Set, Model K712M-5JJY · Traditional | Aalto Scientific, Ltd. | 09/03/2010SE |
| K102016 | Precicontrol Clinchem Multi 1 and 2JJY · Traditional | Roche Diagnostics | 09/01/2010SE |
| K101226 | Audit Microcv Rf/Crp Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 08/31/2010SE |
| K102157 | Elecsys Precicontrol MultimarkerJJY · Traditional | Roche Diagnostics | 08/27/2010SE |
| K101633 | Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighJJY · Traditional | Nova Biomedical Corp. | 08/27/2010SE |
| K093492 | Mission Clinicheck Assayed Chemistry Control, Level 1&2, Mission Clinical CalibratorJJY · Traditional | Diamond Diagnostics, Inc. | 03/19/2010SE |
| K093384 | Mission Trinity R (Level 1) (Level 2) (Level 3), (Level 1,2,3)JJY · Traditional | Diamond Diagnostics, Inc. | 03/10/2010SE |
| K093032 | Triage Total 3 Controls and Calibration Verification SetJJY · Traditional | Biosite Incorporated | 11/13/2009SE |
| K092320 | Elecsys Precicontrol ThyroabJJY · Traditional | Roche Diagnostics | 11/03/2009SE |
| K092051 | Thermo Scientific Mas Chem Trak & Moni Trol H Liquid Assayed Chemistry Control, Model…JJY · Traditional | Microgenics Corp. | 09/21/2009SE |
| K090541 | Elecsys Precicontrol UniversalJJY · Traditional | Roche Diagnostics | 07/02/2009SE |
| K091225 | Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetJJY · Traditional | Maine Standards Co. | 06/25/2009SE |
| K083554 | Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3JJY · Traditional | Cliniqa Corporation | 04/21/2009SE |
| K090475 | Validate CM2 Calibration Verification / Linearity Test Set, Model 402JJY · Traditional | Maine Standards Co. | 04/16/2009SE |
| K083891 | Validate Thyroid Calibration Verification Test Set, Model 901JJY · Traditional | Maine Standards Co. | 03/23/2009SE |
| K082714 | Audit Microcv Therapeutic Drug (TDM) Linearity Set, Model K707M-5JJY · Traditional | Aalto Scientific, Ltd. | 11/19/2008SE |
| K082717 | Audit Microcv Tumor Markers Linearity Set, Model K719M-5JJY · Traditional | Aalto Scientific, Ltd. | 10/30/2008SE |
| K082107 | Cliniqa Liquid QC Urine Chemistry Controls, Levels 1 and 2JJY · Traditional | Cliniqa Corporation | 09/17/2008SE |
| K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakJJY · Traditional | Bio-Rad Laboratories | 09/08/2008SE |
| K082067 | MSC Lipid ControlJJY · Traditional | Maine Standards Co. | 08/22/2008SE |
| K080973 | Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker…JJY · Traditional | Cliniqa Corporation | 06/02/2008SE |
| K073080 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945JJY · Traditional | Bio-Rad Laboratories | 01/24/2008SE |
| K072835 | Liquichek Microalbumin Control Level 1, Level 2, Control MinipakJJY · Traditional | Bio-Rad, Diagnostics Grp. | 12/11/2007SE |
| K072892 | Triage Total Controls 5, Triage Total Calibration Verification 5JJY · Traditional | Biosite Incorporated | 12/07/2007SE |
| K072246 | Validate SP1 Calibration Verification/Linearity Test Set, Model 601JJY · Traditional | Maine Standards Co. | 09/14/2007SE |
| K071980 | Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HJJY · Traditional | Dade Behring, Inc. | 09/11/2007SE |
| K071675 | Liquichek Tumor Marker ControlJJY · Traditional | Bio-Rad Laboratories | 07/03/2007SE |
| K071433 | SMS Glucose Control, Model 2120059JJY · Traditional | Specialty Medical Supplies | 06/28/2007SE |
| K070741 | Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3JJY · Traditional | Cliniqa Corporation | 05/04/2007SE |
| K070504 | Ammonia/Alcohol Control SetJJY · Abbreviated | Pointe Scientific, Inc., | 04/11/2007SE |
| K070200 | TDM Control Set, Model Cat# 04521536JJY · Special | Roche Diagnostics Corp. | 03/19/2007SE |
| K070223 | Audit Microcv Lipids Linearity Set (Low)JJY · Traditional | Aalto Scientific, Ltd. | 03/13/2007SE |
| K062379 | Cobas Integra CeruloplasminJJY · Traditional | Roche Diagnostics Corp. | 01/31/2007SE |
| K062674 | Mission Trinity BJJY · Traditional | Diamond Diagnostics, Inc. | 12/01/2006SE |
| K062593 | Cardiac Markers Control and Calibration Verification Control SetJJY · Traditional | Compass Bioscience | 11/22/2006SE |
| K062916 | Cliniqa Liquid QC Cardiac Marker Control SP, Levels 1,2, &3JJY · Traditional | Cliniqa Corporation | 10/23/2006SE |
| K062668 | Audit Microcv Immunoassay Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 10/16/2006SE |
| K061137 | Advia Ims Cpsa ControlJJY · Abbreviated | Bayer Healthcare, LLC | 07/06/2006SE |
| K061196 | Cardioimmune XL Cardiac Marker ControlJJY · Traditional | Microgenics Corp. | 05/30/2006SE |
| K060850 | Nod Chemistry ControlJJY · Traditional | Bioresource Technology, Inc. | 05/30/2006SE |
| K061182 | Cliniqa Liquid QC Lipid Control Levels 1 & 2;LINICAL Lipid Calibration Verifiers Levels…JJY · Traditional | Cliniqa Corporation | 05/25/2006SE |
| K060206 | Mission CompleteJJY · Traditional | Diamond Diagnostics, Inc. | 03/21/2006SE |
| K060429 | TDM Control SetJJY · Abbreviated | Roche Diagnostics Corp. | 03/15/2006SE |
| K053247 | Validate Cardiac Marker (CM1) Calibration Verification Test SetJJY · Traditional | Maine Standards Co. | 01/13/2006SE |
| K051543 | Elecsys Precicontrol BoneJJY · Traditional | Roche Diagnostics Corp. | 10/17/2005SE |
| K051928 | AUTOCHECK6+JJY · Traditional | Radiometer Medical Aps | 10/12/2005SE |
| K052056 | Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control SerumJJY · Traditional | Thermo-Electron Corp. | 09/23/2005SE |
| K051687 | Elecsys Precicontrol UniversalJJY · Traditional | Roche Diagnostics Corp. | 07/25/2005SE |
| K051185 | Elecsys Ca 19-9 CalcheckJJY · Traditional | Roche Diagnostics Corp. | 07/06/2005SE |
| K051517 | Elecsys Precicontrol AnemiaJJY · Traditional | Roche Diagnostics Corp. | 07/05/2005SE |
| K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…JJY · Traditional | Bio-Rad | 04/27/2005SE |
| K050387 | Roche Diagnostics Elecsys Precicontrol TumorJJY · Special | Roche Diagnostics Corp. | 04/25/2005SE |
| K050504 | Validate Urine Chemistry Calibration Verification Test SetsJJY · Traditional | Maine Standards Co. | 03/25/2005SE |
| K050536 | Quest Diagnostics Immunoassay/Tdm ControlJJY · Traditional | Bio-Rad | 03/24/2005SE |
| K050125 | Rap/Tac/Csa Control - Level 1,2,3,4JJY · Traditional | More Diagnostics | 03/18/2005SE |
| K043208 | Liquid Assayed Multiqual ControlJJY · Traditional | Bio-Rad | 01/07/2005SE |
| K042318 | Audit Microcv General Chemistry Linearity SetJJY · Traditional | Aalto Scientific, Ltd. | 12/09/2004SE |
| K043108 | Liquichek Specialty Immunoassay ControlJJY · Traditional | Bio-Rad Laboratories, Inc. | 12/07/2004SE |
| K042625 | Quikread CRP Calibrator SetJJY · Traditional | Orion Diagnostica, OY | 11/18/2004SE |
| K042815 | Quest Tumor Marker Control, Model 955JJY · Traditional | Bio-Rad | 11/05/2004SE |
| K041975 | Validate Lipoprotein Calibration Verification Test Set, Model 501JJY · Traditional | Maine Standards Co. | 10/15/2004SE |
| K042324 | Lyphochek Elevated Immunosuppressant Control, Level 4, 5JJY · Traditional | Bio-Rad | 10/07/2004SE |
| K042335 | Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model…JJY · Traditional | Bio-Rad Laboratories, Inc. | 09/17/2004SE |
| K042389 | Modification to Precinorm Universal Plus and Precipath Universal Plus Control SeraJJY · Special | Roche Diagnostics Corp. | 09/14/2004SE |
| K041361 | Randox Tri Level Cardiac ControlJJY · Traditional | Randox Laboratories Limited | 09/09/2004SE |
| K041812 | Modification to Roche Diagnostics Precinorm Proteins in Urine/Csf (Puc) and Precipath…JJY · Special | Roche Diagnostics Corp. | 07/27/2004SE |
| K040459 | Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification ControlsJJY · Traditional | Biosite Incorporated | 07/06/2004SE |
| K040379 | Randox Immunoassay ControlJJY · Traditional | Randox Laboratories, Ltd. | 06/16/2004SE |
| K041227 | Modification To:Roche Diagnostics Precinorm Universal and Precipath Universal Control SeraJJY · Special | Roche Diagnostics Corp. | 05/27/2004SE |
| K041073 | Document Salicylate Cal VerJJY · Traditional | Microgenics Corp. | 05/21/2004SE |
| K040822 | Liquichek Torch Plus Igm ControlJJY · Traditional | Bio-Rad Laboratories, Inc. | 05/19/2004SE |
| K040925 | Normal and Hypergamma Control SerumJJY · Traditional | Sebia | 04/28/2004SE |
| K040880 | Mas Cardioimmune TL Liquid Assayed Cardiac Marker Control, Levels 1,2 and 3JJY · Traditional | Medical Analysis Systems, Inc. | 04/28/2004SE |
| K040352 | Nova-One Lipid Control (Special Low Interference Liquid Lipid Control)JJY · Traditional | Bioresource Technology, Inc. | 04/02/2004SE |
| K040535 | Linical Enzyme Calibration Verifiers Levels A-E for Beckman Coulter Synchron SystemsJJY · Traditional | Cliniqa Corporation | 03/29/2004SE |
| K040280 | Precinorm Proteins in Urine/Csf Precipath Proteins in Urine/Csr ControlsJJY · Traditional | Roche Diagnostics Corp. | 03/11/2004SE |
| K040277 | Liquichek Cardiac Marker Control LTJJY · Traditional | Bio-Rad Laboratories, Inc. | 03/10/2004SE |
| K040273 | Lyphochek Assayed Chemistry ControlJJY · Traditional | Bio-Rad Laboratories, Inc. | 03/04/2004SE |
| K040091 | Linical Esoterics Calibration Verifiers Levels A-E for Olympus Au SystemsJJY · Traditional | Cliniqa Corporation | 02/23/2004SE |
| K033344 | Ligand Plus Control Level 1-3JJY · Traditional | Consolidated Technology | 01/16/2004SE |
| K033937 | Elecsys Precicontrol MultianalyteJJY · Traditional | Roche Diagnostics Corp. | 01/07/2004SE |
| K033379 | Bayer Special Chemistry ControlsJJY · Abbreviated | Bayer Diagnostics Corp. | 12/19/2003SE |
| K033387 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945JJY · Traditional | Bio-Rad | 12/02/2003SE |
| K032074 | Linical Esoterics Calibration Verifiers Levels A-E for Beckman Coulter Synchron AnalyzersJJY · Traditional | Cliniqa Corporation | 10/21/2003SE |
| K033162 | Linical Chemistry Calibration Verifiers Levels A-E for Olympus Au SystemsJJY · Traditional | Cliniqa Corporation | 10/10/2003SE |
| K032122 | Audit Microcontrols Microfd BNP ControlJJY · Traditional | Aalto Scientific, Ltd. | 09/09/2003SE |
| K032237 | N/T Protein ControlJJY · Traditional | Dade Behring, Inc. | 09/05/2003SE |
| K032453 | Roche Combitrol and Autotrol Plus B Multi Analyte ControlJJY · Traditional | Bionostics, Inc. | 08/28/2003SE |
| K031921 | Linical Chemistry Calibration Verifiers Levels a - E for Beckman Coulter Synchron SystemsJJY · Traditional | Cliniqa Corporation | 08/25/2003SE |
| K032335 | Mas Cardioimmune Probnp, Mas Cardioimmune TLJJY · Traditional | Medical Analysis Systems, Inc. | 08/19/2003SE |
| K031577 | Linical Protein 2 Calibration Verifiers Levels A-E for Beckman Coulter Array Protein…JJY · Traditional | Cliniqa Corporation | 08/06/2003SE |
| K032089 | Roche Diagnostics Elecsys Precicontrol CardiacJJY · Special | Roche Diagnostics Corp. | 07/30/2003SE |
| K031575 | Linical Protein 2 Calibration Verifiers Levels A-E for Olympus Au AnalyzersJJY · Traditional | Cliniqa Corporation | 07/23/2003SE |
| K031644 | Bayer Advia Chemistry Special Chemistry ControlJJY · Abbreviated | Bayer Healthcare, LLC | 06/25/2003SE |
| K031101 | Raichem Assayed Control Serum Level 1 & 2JJY · Abbreviated | Hemagen Diagnostics, Inc. | 06/16/2003SE |
| K031364 | Mas Cardiolmmune Probnp Liquid Assayed Cardiac Marker Control Level 1, 2 and 3JJY · Traditional | Medical Analysis Systems, Inc. | 05/30/2003SE |
| K030942 | Mas Chemtrak H & Dade Moni-Trol H Liquid Assayed Chemistry ControlJJY · Traditional | Medical Analysis Systems, Inc. | 04/28/2003SE |
| K030801 | Bayer Advia 1650 Special Chemistry ControlJJY · Abbreviated | Bayer Healthcare, LLC | 04/09/2003SE |
| K030705 | Cliniqa Liquid QC Tumor Marker Control Level 1, Level 2, Level 3, and Tri LevelJJY · Traditional | Cliniqa Corporation | 03/26/2003SE |
| K030482 | Wiener Lab. Standatrol S-E 2 Niveles, Lovels 1&2: 3X5 ML Vials CAT.NR.1937553JJY · Traditional | Wiener Laboratories | 03/19/2003SE |
| K030679 | Mas Lipid Level 1 and 2JJY · Traditional | Medical Analysis Systems, Inc. | 03/14/2003SE |
| K030566 | Linical Protein 3 Calibration Verifiers Levels A-E for the Olympus Au Series Chemistry…JJY · Traditional | Cliniqa Corporation | 03/13/2003SE |
| K030452 | Bayer Ligand Plus 1, 2, 3 ControlsJJY · Abbreviated | Bayer Diagnostics Corp. | 03/03/2003SE |
| K030150 | Linical Protein 5 Calibration Verifiers Levels A-E for Beckman Coulter Array and Immage…JJY · Traditional | Cliniqa Corporation | 01/28/2003SE |
| K030089 | Triage Cardiac Controls; Triage Cardio Profiler ControlsJJY · Traditional | Biosite Incorporated | 01/23/2003SE |
| K030088 | Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration…JJY · Traditional | Biosite Incorporated | 01/17/2003SE |
| K023410 | Validate Chem 10 Calibration Verification Test Set, Model 110JJY · Traditional | Maine Standards Co. | 01/06/2003SE |
| K023731 | Quickcheck Liquid Chemistry Control (Assayed and Unassayed), Levels 1, 2, and 3JJY · Traditional | Consolidated Technology | 12/24/2002SE |
| K023669 | Mas Cardioimmune TL Low Level Liquid Assayed Cardiac Marker Control, Dade Cardiac TL Low…JJY · Traditional | Medical Analysis Systems, Inc. | 12/19/2002SE |
| K023867 | Mas T-Marker, Level 1,2 and 3, Dade Special-T Marker, Level 1,2 and 3JJY · Traditional | Medical Analysis Systems, Inc. | 12/17/2002SE |
| K023661 | Linical Rf-Crp Calibration Verifiers Levels A-E for Beckman Coulter Synchron CX SystemsJJY · Traditional | Cliniqa Corporation | 12/06/2002SE |
| K023352 | Validate Chem 9 Calibration Verification Test Set, Model 109JJY · Traditional | Maine Standards Co. | 11/22/2002SE |
| K023250 | Linical Protein 2 Calibration Verifiers Levels A-E for the Beckman-Coulter ImmageJJY · Traditional | Cliniqa Corporation | 10/17/2002SE |
| K022936 | Linical Hscrp Calibration Verifiers Levels A-E for Beckman Coulter ImmageJJY · Traditional | Cliniqa Corporation | 10/02/2002SE |
| K022885 | Linical Protein 4 Calibration Verifiers Levels-A-E for Beckman Coulter ImmageJJY · Traditional | Cliniqa Corporation | 10/02/2002SE |
| K022867 | Linical Protein 3 Calibration Verifiers Levels a - E for the Beckman-Coulter ImmageJJY · Traditional | Cliniqa Corporation | 10/02/2002SE |
| K022851 | PH and Amines External Control SetJJY · Traditional | Quidel Corp. | 09/27/2002SE |
| K022991 | Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2…JJY · Traditional | Bio-Rad | 09/17/2002SE |
| K022591 | Randox Lipid ControlJJY · Traditional | Randox Laboratories, Ltd. | 08/30/2002SE |
| K022401 | PTS Panels Multi-Chemistry ControlsJJY · Traditional | Polymer Technology Systems, Inc. | 08/21/2002SE |
| K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563JJY · Traditional | Bio-Rad Laboratories, Inc. | 07/16/2002SE |
| K021930 | Medica Easyqc Blood Gas/Electrolyte ControlJJY · Traditional | Bionostics, Inc. | 06/25/2002SE |
| K021381 | Modification to N/T Rheumatology Controls SL 1 & 2JJY · Traditional | Dade Behring, Inc. | 06/10/2002SE |
| K020817 | Liquichek Urine Chemistry ControlJJY · Traditional | Bio-Rad Laboratories, Inc. | 04/12/2002SE |
| K020450 | Validate Chem 8 Calibration Verification Test Set; Model 108JJY · Traditional | Maine Standards Co. | 03/21/2002SE |
| K020237 | Immunoassay Plus Control, Levels 1, 2, and 3JJY · Traditional | Consolidated Technology | 03/19/2002SE |
| K020521 | Modification to Vigil Lipid ControlJJY · Special | Beckman Coulter, Inc. | 03/01/2002SE |
| K013995 | Modification to Mas Cardiolmmune TL; Dade Cardiac TLJJY · Traditional | Medical Analysis Systems, Inc. | 12/21/2001SE |
| K013734 | Mas Lipid Control, Liquid Assayed Lipid Control, Level 1 and 2, Dade Lipid Control…JJY · Special | Medical Analysis Systems, Inc. | 12/07/2001SE |
| K013332 | Linical Protein I Calibration Verifiers Levels A=E for Beckman Coulter ImmageJJY · Traditional | Cliniqa Corporation | 11/20/2001SE |
| K013265 | Validate Chem 7 Calibration Verification Test Set, Model 10007JJY · Traditional | Maine Standards Co. | 11/20/2001SE |
| K013235 | Modification to Synchron ControlJJY · Special | Beckman Coulter, Inc. | 10/16/2001SE |
| K012468 | Modification to N/T Protein Control SLJJY · Traditional | Dade Behring, Inc. | 09/04/2001SE |
| K012855 | Liquispx Liquid Lipid ControlJJY · Traditional | Clinical Controls Division | 08/30/2001SE |
| K012513 | Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642JJY · Traditional | Bio-Rad | 08/29/2001SE |
| K012431 | Combitrol TS Multi Analyte Control, Levels 1,2,3, Autotrol TS Multi Analyte Control…JJY · Traditional | Bionostics, Inc. | 08/28/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0538-2026 Class III | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials…A labeling error was identified on the affected product. The expiration date on the kit box label and on the… | Polymedco, Inc. / Polymedco Cancer… | 10/06/2025Open, Classified |
| Z-0415-2026 Class II | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control…The firm received complaints from customers reporting vial-to-vial variability when using the control with… | Microgenics Corporation | 10/01/2025Open, Classified |
| Z-1839-2025 Class II | HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.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-1838-2025 Class II | HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.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-1824-2025 Class II | ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROLtransit 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-1373-2024 Class II | VITROS Performance Verifier IIThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II.… | Ortho-Clinical Diagnostics | 02/27/2024Open, Classified |
| Z-1372-2024 Class II | VITROS Performance Verifier IThe issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II.… | Ortho-Clinical Diagnostics | 02/27/2024Open, Classified |
| Z-1315-2024 Class II | Abbott Point of Care Control Control i-STAT Level 3 1.7 mLFacility 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-1314-2024 Class II | Abbott Point of Care Control Control i-STAT Level 1 10 X 1.7 mLFacility 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-0106-2024 Class II | Multichem P, Part Code 08P90-10Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the… | Techno-Path Manufacturing Ltd. | 08/25/2023Open, Classified |
| Z-0105-2024 Class II | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the… | Techno-Path Manufacturing Ltd. | 08/25/2023Open, Classified |
| Z-0104-2024 Class II | Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the… | Techno-Path Manufacturing Ltd. | 08/25/2023Open, Classified |
| Z-2609-2023 Class II | Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry… | Randox Laboratories Ltd. | 08/03/2023Open, Classified |
| Z-2446-2023 Class II | Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the…(1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be… | Randox Laboratories Ltd. | 06/21/2023Open, Classified |
| Z-2022-2023 Class III | Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality…Delay in reporting results due to Quality Controls running high outside of range. Target value and range for… | Randox Laboratories Ltd. | 05/04/2023Open, Classified |
| Z-2021-2023 Class III | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material…Delay in reporting results due to Quality Controls running high outside of range. Target value and range for… | Randox Laboratories Ltd. | 05/04/2023Open, Classified |
| Z-0905-2023 Class II | Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | Randox Laboratories Ltd. | 11/22/2022Open, Classified |
| Z-0904-2023 Class II | Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | Randox Laboratories Ltd. | 11/22/2022Open, Classified |
| Z-0903-2023 Class II | Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of…Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in… | Randox Laboratories Ltd. | 11/22/2022Open, Classified |
| Z-1337-2022 Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IIToo low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | Chromsystems Instruments & Chemicals GmbH | 05/19/2022Terminated |
| Z-1336-2022 Class II | MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level IToo low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products. | Chromsystems Instruments & Chemicals GmbH | 05/19/2022Terminated |
| Z-0539-2021 Class II | MassChrom Amino Acid Analysis Plasma Control Level III, Order No. 0473 - Product Usage:…XXX | Chromsystems Instruments & Chemicals GmbH | 11/02/2020Terminated |
| Z-0538-2021 Class II | MassChrom Amino Acid Analysis Plasma Control Level II, Order No. 0472 - Product Usage:…XXX | Chromsystems Instruments & Chemicals GmbH | 11/02/2020Terminated |
| Z-0537-2021 Class II | MassChrom Amino Acid Analysis Plasma Control Level I, Order No. 0471 - Product Usage:…Products do not meet stability criteria and may impact results. | Chromsystems Instruments & Chemicals GmbH | 11/02/2020Terminated |
| Z-0523-2021 Class II | MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage:…Control lots may not meet stability criteria and could result in increased results of patient samples for… | Chromsystems Instruments & Chemicals GmbH | 10/29/2020Completed |
| Z-0522-2021 Class II | MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage:…Control lots may not meet stability criteria and could result in increased results of patient samples for… | Chromsystems Instruments & Chemicals GmbH | 10/29/2020Completed |
| Z-0471-2021 Class III | VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use…Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot… | Ortho Clinical Diagnostics Inc | 10/16/2020Open, Classified |
| Z-3054-2020 Class II | Control, Calibrator Verified, Triage BNP, Model ALR88755Product was shipped with refrigeration (ice) instead of frozen (dry ice). | Medline Industries Inc | 07/28/2020Terminated |
| Z-2407-2020 Class III | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label…The product has an incorrect reference value for cadmium and an incorrect expected range. | Utak Laboratories Inc | 03/20/2020Terminated |
| Z-1547-2020 Class II | Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This…The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly. | Randox Laboratories Ltd. | 02/18/2020Open, Classified |
| Z-1100-2020 Class III | Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 mlA transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry… | Randox Laboratories Ltd. | 12/13/2019Terminated |
| Z-0414-2020 Class II | Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed… | Randox Laboratories, Limited | 10/04/2019Terminated |
| Z-0413-2020 Class II | Randox Liquid Cardiac Controls Catalogue Number CQ5052.Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed… | Randox Laboratories, Limited | 10/04/2019Terminated |
| Z-0412-2020 Class II | Randox Liquid Cardiac Controls Catalogue Number CQ5051Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed… | Randox Laboratories, Limited | 10/04/2019Terminated |
| Z-2150-2019 Class II | Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is…The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT… | Randox Laboratories, Limited | 06/11/2019Terminated |
| Z-2207-2019 Class III | Assayed Bovine Multi-Sera Level 1, Model No. AL1027The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation… | Randox Laboratories, Limited | 06/10/2019Terminated |
| Z-1363-2019 Class III | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1362-2019 Class III | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is…Devices were delivered without the required dry ice. | Abbott Laboratories | 04/09/2019Terminated |
| Z-1461-2020 Class II | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as…The form received three complaints related to the user obtaining a result that fell below the target range… | Response Biomedical Corp. | 03/15/2019Terminated |
| Z-1785-2019 Class II | Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac… | Randox Laboratories Ltd. | 03/11/2019Terminated |
| Z-1057-2019 Class II | Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of…An error in the assignment of the control range pH in Blood Gas Control | Randox Laboratories Ltd. | 02/13/2019Terminated |
| Z-1107-2019 Class III | Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | Randox Laboratories Ltd. | 02/07/2019Terminated |
| Z-1106-2019 Class III | Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | Randox Laboratories Ltd. | 02/07/2019Terminated |
| Z-1105-2019 Class III | Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This…The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this… | Randox Laboratories Ltd. | 02/07/2019Terminated |
| Z-0382-2019 Class II | Liquid Cardiac Control, CQ5053Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8… | Randox Laboratories Ltd. | 10/02/2018Terminated |
| Z-0381-2019 Class II | Liquid Cardiac Control, CQ5052Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8… | Randox Laboratories Ltd. | 10/02/2018Terminated |
| Z-0380-2019 Class II | Liquid Cardiac Control, CQ5051Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8… | Randox Laboratories Ltd. | 10/02/2018Terminated |
| Z-2575-2018 Class II | Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is…The device is not suitable for the control of the Troponin T assay due to unacceptable variation between… | Randox Laboratories Ltd. | 06/08/2018Terminated |
| Z-2280-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | Randox Laboratories Ltd. | 05/22/2018Terminated |
| Z-2279-2018 Class II | Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein Controls… | Randox Laboratories Ltd. | 05/22/2018Terminated |