Bio-Rad Laboratories, Inc.
Medical device manufacturer in Woodinville, WA.
127510(k) clearances
4PMA approvals
88recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 26
- LCP Assay, Glycosylated Hemoglobin 8
- DIF Drug Mixture Control Materials 5
- LOL Hepatitis A Test (Antibody And Igm Antibody) 4
- CDP Radioimmunoassay, Total Triiodothyronine 3
- LJC Enzyme Linked Immunoabsorbent Assay… 3
- DHB System, Test, Radioallergosorbent (Rast)… 3
- JJX Single (Specified) Analyte Controls… 3
- LIP Enzyme Linked Immunoabsorption Assay… 3
- PDJ Hemoglobin A1c Test System 3
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- CFT Radioimmunoassay, Prolactin (Lactogen) 2
- CGR Radioimmunoassay, Cortisol 2
- CDD Radioassay, Vitamin B12 2
- JPK Mixture, Hematology Quality Control 2
- LKJ Antinuclear Antibody, Antigen, Control 2
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- LSE Epstein-Barr Virus, Other 2
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 2
- GKA Abnormal Hemoglobin Quantitation 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K183446 | BioPlex 2200 Lyme TotalLSR · Traditional | 03/12/2019SE |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX · Traditional | 02/13/2019SE |
| K180577 | BioPlex 2200 25-OH Vitamin D KitMRG · Traditional | 06/22/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | 09/13/2017SE |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…PUQ · Traditional | 05/19/2017SE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional | 05/11/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | 01/10/2017SE |
| K161687 | D-10 Hemoglobin A1c ProgramPDJ · Traditional | 10/14/2016SE |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level…PMN · Traditional | 05/10/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | 12/11/2015SE |
| K151321 | D-100 HbA1c, D-100 HbA1c Calibrator PackPDJ · Traditional | 12/09/2015SE |
| K142448 | VARIANT II TURBO HbA1c Kit - 2.0PDJ · Traditional | 03/24/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | 03/13/2015SE |
| K141114 | Bioplex(R) 2200 25-OH Vitamin D Kit, Bioplex(R) 2200 25-OH Vitamin D Calibrator Set, and…MRG · Traditional | 01/09/2015SE |
| K140801 | Variant II Turbo Link Hemoglobin A1C Program/Testing SystemLCP · Special | 06/25/2014SE |
| K141073 | Liquichek Tumor Marker ControlJJY · Traditional | 06/23/2014SE |
| K140916 | Liquichek Cardiac Troponins Control, Levels 1,2 and 3, Trilevel/MinipakJJY · Traditional | 05/06/2014SE |
| K140764 | Liquichek Immunologycontrol-Level 1,LEVEL 2, Level 3, MinipakJJY · Traditional | 04/25/2014SE |
| K134013 | Lyphochek Allergen Sige Control, Negative, Lypochek Allergen Sige Control, Negative…JJY · Traditional | 04/24/2014SE |
| K133960 | Lypochek Specialty Immunoassay ControlJJY · Traditional | 01/22/2014SE |
| K132227 | Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium…JJY · Traditional | 10/25/2013SE |
| K130528 | Bioplex 2200 Apls IgmMID · Traditional | 10/21/2013SE |
| K130053 | Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…MVM · Traditional | 09/19/2013SE |
| K130963 | Liquichek Pediatric Control, Level 1; Liquichek Pediatric Contol, Level 2; Liquichek…JJY · Traditional | 05/06/2013SE |
| K130761 | Liquichek Immunology Control, Level 1,2,3, Trilevel MinipakJJY · Traditional | 04/12/2013SE |
| K130162 | Liquid Assayed Multiqual PremiumJJY · Traditional | 03/01/2013SE |
| K123775 | Liquichek Spinal Fluid Control Level 1, Liquichek Spinal Fluid Control Level 2…JJY · Traditional | 01/31/2013SE |
| K123798 | Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel MinipakJJX · Traditional | 01/09/2013SE |
| K123663 | Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel MinipakJJY · Traditional | 12/27/2012SE |
| K123198 | Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control…JJY · Traditional | 11/20/2012SE |
| K123021 | Bioplex 2200 Ebv Igm KitLJN · Traditional | 11/02/2012SE |
| K122838 | Liquickek Immunoassay Plus Control, Level 1 Model 267, Liquichek Immunoassay Plus…JJY · Traditional | 10/17/2012SE |
| K113610 | Ana-Screen with MDSSLKJ · Special | 07/09/2012SE |
| K120959 | Bioplex 2200 HSV-1 and HSV-2 Igg KitMXJ · Traditional | 06/22/2012SE |
| K121143 | Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)DIF · Traditional | 05/18/2012SE |
| K103834 | Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control SetsMID · Traditional | 03/30/2012SE |
| K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology…DIF · Traditional | 03/27/2012SE |
| K120572 | Bioplex 2200 Torc IggOMI · Special | 03/26/2012SE |
| K120439 | Bioplex 2200 Ebv Igg and Syphilis IggLIP · Special | 03/14/2012SE |
| K112810 | Multi-Analyte Detection SystemsNHX · Special | 10/26/2011SE |
| K111072 | Bioplex 2200 MMRV Igg It on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200…OPL · Special | 08/23/2011SE |
| K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemLFX · Traditional | 12/03/2010SE |
| K093954 | Bioplex 2200 Anti-Ccp Kit on the Bioplex 2200 Multi-Analyte Detection SystemNHX · Traditional | 08/24/2010SE |
| K091303 | Liquichek HEMATOLOGY-16 Control LV, Model: 295LVJPK · Traditional | 08/02/2010SE |
| K091616 | Bioplex 2200 MMRV IggOPL · Traditional | 03/29/2010SE |
| K093577 | Liquichek Opiate ControlDIF · Traditional | 03/12/2010SE |
| K092355 | Monolisa Anti-Hav EiaLOL · Traditional | 10/29/2009SE |
| K092353 | Monolisa Anti-Hav Igm EiaLOL · Traditional | 10/29/2009SE |
| K090699 | Variant II Turbo HBA1C Kit KIT-20 and Wash/Diluent Solution Set, Models 270-2455, 270-2730LCP · Traditional | 07/27/2009SE |
| K090847 | Platelia Toxo Igm Kit Model 26211LGD · Special | 07/01/2009SE |
| K090737 | Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection…JKA · Traditional | 06/03/2009SE |
| K090409 | Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemMXJ · Traditional | 05/08/2009SE |
| K080008 | Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetOMI · Traditional | 02/23/2009SE |
| K082036 | Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and MinipakJJY · Traditional | 09/08/2008SE |
| K073080 | Quest Diagnostics Serum Chemistry Control, Models 935 and 945JJY · Traditional | 01/24/2008SE |
| K072358 | Bioplex Vasculitis KitMVJ · Traditional | 10/31/2007SE |
| K071675 | Liquichek Tumor Marker ControlJJY · Traditional | 07/03/2007SE |
| K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NULCP · Traditional | 05/07/2007SE |
| K063319 | Monolisa Anti-Hav Igm EiaLOL · Traditional | 05/03/2007SE |
| K063318 | Monolisa Anti-Hav EiaLOL · Traditional | 05/03/2007SE |
| K070546 | Lyphochek Diabetes ControlGGM · Traditional | 04/02/2007SE |
| K063866 | Bioplex 2200 Syphilis Igg Kit on the Bioplex 2200 Multi-Analyte Detection SystemLIP · Traditional | 03/19/2007SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | 12/08/2006SE |
| K063400 | Variant II Turbo Hemoglobin A1C Program, Hemoglobin Testing System with CDM 4.0LCP · Special | 12/01/2006SE |
| K060001 | D-10 Hemoglobin A1C Program; D-10 Dual ProgramLCP · Special | 01/20/2006SE |
| K043341 | Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200…NVI · Traditional | 10/27/2005SE |
| K051072 | Bio-Rad Variant NBS Sickle Cell ProgramGKA · Traditional | 05/12/2005SE |
| K050682 | Liquichek Urine Toxicology Control (Level C1)DIF · Traditional | 04/29/2005SE |
| K043584 | Liquichek BNP ControlJJX · Traditional | 02/08/2005SE |
| K041658 | Bioplex 200 Ana Screen on the Bioplex 2200 Multi-Analyte Detection System, Model Bioplex…LKJ · Traditional | 12/20/2004SE |
| K043108 | Liquichek Specialty Immunoassay ControlJJY · Traditional | 12/07/2004SE |
| K042446 | Quantify Control and Quantify Plus ControlsJJW · Traditional | 11/02/2004SE |
| K042336 | Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel MinipakJPK · Traditional | 10/14/2004SE |
| K042335 | Architect Free Psa Mastercheck, Model 6C07-05; Architect Tital Psa Mastercheck, Model…JJY · Traditional | 09/17/2004SE |
| K041444 | Bio-Rad D-10 Dual ProgramLCP · Traditional | 06/09/2004SE |
| K040822 | Liquichek Torch Plus Igm ControlJJY · Traditional | 05/19/2004SE |
| K040872 | Variant II Hemoglobin A1CLCP · Traditional | 04/15/2004SE |
| K040277 | Liquichek Cardiac Marker Control LTJJY · Traditional | 03/10/2004SE |
| K040273 | Lyphochek Assayed Chemistry ControlJJY · Traditional | 03/04/2004SE |
| K033924 | Liquichek Urine Toxicology Control (Screen Series)DIF · Traditional | 02/03/2004SE |
| K031043 | D-10 Hemoglobin A1CLCP · Traditional | 08/27/2003SE |
| K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563JJY · Traditional | 07/16/2002SE |
| K020817 | Liquichek Urine Chemistry ControlJJY · Traditional | 04/12/2002SE |
| K970126 | Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)CHP · Traditional | 02/25/1997SE |
| K960850 | Access Chlamydia AssayLJC · Traditional | 02/04/1997SE |
| K963934 | Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320…MMI · Traditional | 12/16/1996SE |
| K954687 | Access Rubella IggLFX · Traditional | 04/09/1996SE |
| K960913 | Access Free T3 AssayCDP · Traditional | 03/29/1996SE |
| K955769 | Access Progesterone AssayJLS · Traditional | 02/05/1996SE |
| K955436 | Access Vitamin B12 Assay (Modification)CDD · Traditional | 01/24/1996SE |
| K955435 | Access Total T3 Assay (Modification)CDP · Traditional | 01/24/1996SE |
| K951495 | Access Toxo Igg Assay on the Access Immunoassay SystemLGD · Traditional | 12/20/1995SE |
| K954733 | Access Cortisol Assay (Modification)CGR · Traditional | 12/05/1995SE |
| K954825 | Access Hypersensitive TSH Reagents on the Access Immunoassay AnalyzerJLW · Traditional | 11/21/1995SE |
| K954732 | Access Total BHCG Assay (Modification)JHI · Traditional | 11/20/1995SE |
| K953883 | Access Low Level Ige ControlsJJX · Traditional | 11/14/1995SE |
| K953780 | Access Allergen Dog EpithelimDHB · Traditional | 11/14/1995SE |
| K954680 | Access Prolactin Assay (Modification)CFT · Traditional | 10/20/1995SE |
| K951634 | Access Myoglobin ReagentsDDR · Traditional | 09/27/1995SE |
| K953084 | Access Ultrasensitive Insulin AssayCFP · Traditional | 09/25/1995SE |
| K950629 | Access Allergens - Fematophagoides Farinae, Cat Dander, Timothy Grass, and Alternaria…DHB · Traditional | 05/23/1995SE |
| K935807 | Access(R) Chlamydia Eia and Blocking AssayLJC · Traditional | 05/19/1995SE |
| K945083 | Access Ck-Mb ReagentsJHS · Traditional | 11/21/1994SE |
| K935393 | Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking AssayLJC · Traditional | 09/20/1994SE |
| K940833 | Access(R) Total T3CDP · Traditional | 09/07/1994SE |
| K941175 | Access ProlactinCFT · Traditional | 06/02/1994SE |
| K940221 | Access Cortisol ReagentsCGR · Traditional | 04/26/1994SE |
| K940549 | Access(R) Human Luteinzing Hormone AssayCEP · Traditional | 04/06/1994SE |
| K935876 | Access Specific Ige AssayDHB · Traditional | 03/11/1994SE |
| K940005 | Access Human Follicle Stimulating Hormone AssayCGJ · Traditional | 03/03/1994SE |
| K933142 | Access Vitamin B12 AssayCDD · Traditional | 11/05/1993SE |
| K926475 | Access(R) Thyroxine AssayKLI · Traditional | 06/15/1993SE |
| K930984 | Access(R) Total Ige AssayDGC · Traditional | 06/09/1993SE |
| K930010 | Access Thyroid Uptake AssayCEE · Traditional | 06/07/1993SE |
| K926322 | Access(R) Cortisol ReagentsJFT · Traditional | 05/26/1993SE |
| K925637 | Access HTSH AssayJLW · Traditional | 03/01/1993SE |
| K923316 | Expresso CartridgeJQP · Traditional | 02/23/1993SE |
| K924289 | Kallestad RSV Microplate EiaMCE · Traditional | 02/12/1993SE |
| K926198 | Access Total BHCG AssayJHI · Traditional | 02/08/1993SE |
| K925913 | Access(R) Free T4 AssayCEC · Traditional | 01/27/1993SE |
| K926221 | Access Ferritin AssayJMG · Traditional | 01/13/1993SE |
| K925802 | Access Digoxin AssayKXT · Traditional | 01/13/1993SE |
| K924087 | Kalestad Ana Microplate EiaLJM · Traditional | 11/02/1992SE |
| K922823 | Access Theophylline Immunoassay ReagentsCGN · Traditional | 08/05/1992SE |
| K915137 | Kallestad Rotavirus MicroplateLIQ · Traditional | 03/04/1992SE |
| K912800 | Kallestead Total Ige Microplate KitDGC · Traditional | 07/25/1991SE |
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2515-2025 Class II | Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM…Due to a risk of false positive results that could lead to unnecessary medical treatment. | 05/30/2025Open, Classified |
| Z-1358-2024 Class II | Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS KitDue to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and… | 02/15/2024Open, Classified |
| Z-1572-2023 Class II | BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent PackAPLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in… | 02/28/2023Open, Classified |
| Z-1378-2023 Class II | BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVDBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot… | 02/21/2023Open, Classified |
| Z-1377-2023 Class II | BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVDBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot… | 02/21/2023Open, Classified |
| Z-0342-2023 Class II | CMV IgM EIA, in vitro diagnostic.Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme… | 10/19/2022Open, Classified |
| Z-1096-2022 Class II | BioPlex 2200 REF 12000670 ToRC IgM Reagent PackPerformance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background… | 04/14/2022Open, Classified |
| Z-1208-2022 Class II | Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack…The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number:… | 04/07/2022Open, Classified |
| Z-0807-2022 Class II | BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CALDue to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200… | 02/08/2022Open, Classified |
| Z-0806-2022 Class II | BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent PackDue to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200… | 02/08/2022Open, Classified |
| Z-0236-2022 Class II | BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex…Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR)… | 09/17/2021Open, Classified |
| Z-0235-2022 Class II | BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The…Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR)… | 09/17/2021Open, Classified |
| Z-2982-2020 Class II | BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema…The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650. | 04/21/2020Open, Classified |
| Z-0082-2022 Class II | BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent…A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of… | 11/01/2019Terminated |
| Z-1906-2019 Class II | EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software…User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat… | 01/10/2019Open, Classified |
| Z-1743-2019 Class II | MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for…Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. | 06/08/2018Terminated |
| Z-1742-2019 Class II | MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is…Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. | 06/08/2018Terminated |
| Z-2541-2018 Class II | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100…The connector of the power supply was capable of fitting other components provided with the system. However… | 04/02/2018Terminated |
| Z-0807-2016 Class II | EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's…The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system… | 12/22/2015Terminated |
| Z-0695-2016 Class II | D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated…On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running… | 12/15/2015Terminated |
| 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… | 05/13/2015Terminated |
| Z-1537-2014 Class II | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and…There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration… | 04/08/2014Terminated |
| Z-1299-2014 Class II | D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad…On a rare occasion the D-10 software might generate an extra result by duplicating the result form the… | 02/27/2014Terminated |
| Z-0965-2014 Class III | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States…D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being… | 11/22/2013Terminated |
| Z-0032-2014 Class III | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade…The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the… | 08/20/2013Terminated |
| Z-1330-2013 Class III | Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is…The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated… | 04/15/2013Terminated |
| Z-2398-2012 Class II | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog…Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated… | 07/27/2012Terminated |
| Z-0399-2012 | VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the…It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC… | 10/25/2011Terminated |
| Z-0027-2012 | VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0026-2012 | VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0025-2012 | VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0024-2012 | VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0023-2012 | VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0022-2012 | VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0021-2012 | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0020-2012 | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0019-2012 | D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547.…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0018-2012 | D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547.…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0017-2012 | D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-3159-2011 | VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD.…The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. | 07/28/2011Terminated |
| Z-2889-2011 | D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include…Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435. | 07/11/2011Terminated |
| Z-2082-2011 | BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part:…Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the… | 03/11/2011Terminated |
| Z-1726-2011 | PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is…Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS)… | 01/20/2011Terminated |
| Z-1650-2011 | BIO-RAD BioPlex 2200 Syphilis IgG Control Set. Lot # 46636 The BioPlex 2200 Syphilis IgG…An upward shift in the control values can result in a control value that falls outside of the current… | 11/23/2010Terminated |
| Z-0109-2011 | in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges…Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results. | 09/07/2010Terminated |
| Z-0122-2011 | in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test…Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for… | 07/26/2010Terminated |
| Z-2201-2011 | Software CD is labeled in part: "BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF…The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of… | 07/19/2010Terminated |
| Z-3051-2011 | "BIO-RAD Kallestad Mouse Stomach/Kidney 8 Well Slides, Bio-Rad Laboratories, STORE…KALLESTAD Mouse Stomach/Kidney (MSK) test kits contained Crithidia slides instead of the MSK slides. | 06/30/2010Terminated |
| Z-0612-2011 | Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed…Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect… | 06/24/2010Terminated |
| Z-1846-2011 | The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by:…The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of… | 04/22/2010Terminated |
| Z-1984-2011 | VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in…The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen… | 04/14/2010Terminated |
| Z-1342-2011 | Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog…The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a… | 03/24/2010Terminated |
| Z-1648-2011 | Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 576 Tests, Catalog No. 576DS…The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. | 03/02/2010Terminated |
| Z-1647-2011 | Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS…The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. | 03/02/2010Terminated |
| Z-1479-2011 | Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY.…The firm received customer complaints of increased positivity rates associated with the ANA Screening kit… | 03/01/2010Terminated |
| Z-1478-2011 | DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad…Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. | 03/01/2010Terminated |
| Z-0540-2011 | Autoimmune EIA ANA Screening Test Kit, 576 Tests, Model/Catalog Number: 576AN…The ANA Screening kit generates a high percentage of false positive results, associated with a low check… | 03/01/2010Terminated |
| Z-0539-2011 | Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured…The ANA Screening kit generates a high percentage of false positive results, associated with a low check… | 03/01/2010Terminated |
| Z-0608-2011 | Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad…The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually… | 02/26/2010Terminated |
| Z-0613-2011 | Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261…False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive… | 02/24/2010Terminated |
| Z-1259-2011 | Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program…The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The… | 02/19/2010Terminated |
| Z-1562-2011 | Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2…Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for… | 01/26/2010Terminated |
| Z-1898-2011 | Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin…Wrong lot number was found on the Hemoglobin Cartridge Insert . The insert did not match the lot number to… | 12/08/2009Terminated |
| Z-1932-2011 | Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge…Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping… | 12/01/2009Terminated |
| Z-0867-2010 | Variant II Turbo Hemoglobin A1c Program, model number 270 2417, manufactured by Bio-Rad…Product update kit CD rom will not upload. As a result, the device cannot be run. | 10/12/2009Terminated |
| Z-1495-2011 | PhD System EIA/IFAversion 2.1A software, model number 426-0246, a component of the…Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme… | 09/29/2009Terminated |
| Z-1145-2010 | BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot…The firm received customer complaints of microbial contamination in Positive Controls in its… | 07/14/2009Terminated |
| Z-1013-2010 | Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set…Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run… | 06/15/2009Terminated |
| Z-1902-2010 | VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model…Sample test results for the first run appears to be correct but all subsequent results during that run were… | 01/22/2009Terminated |
| Z-1901-2010 | VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number:…Sample test results for the first run appears to be correct but all subsequent results during that run were… | 01/22/2009Terminated |
| Z-1395-2009 | Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number 270-2000…The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample… | 12/09/2008Terminated |
| Z-1041-2009 | Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number…Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant… | 10/17/2008Terminated |
| Z-0908-2010 | Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1…Elevated optical density (OD) values with the kit Negative Control. | 08/20/2008Terminated |
| Z-1620-2010 | Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA…The package insert provided with this kit contains a typographical error, giving incorrect directions to… | 08/11/2008Terminated |
| Z-2430-2008 | Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney…The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128… | 07/29/2008Terminated |
| Z-2429-2008 | Kallestad (TM) Mouse Stomach/Kidney, catalog number 30443 - 8 wells, 48 tests. Product…The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128… | 07/29/2008Terminated |
| Z-2428-2008 | Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2…The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128… | 07/29/2008Terminated |
| Z-1589-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500…Some product ROM cards have an incorrect program loaded and are unable to be updated. | 03/18/2008Terminated |
| Z-1588-2008 | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250…Some product ROM cards have an incorrect program loaded and are unable to be updated. | 03/18/2008Terminated |
| Z-1189-2008 | Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for… | 01/07/2008Terminated |
| Z-1159-2008 | BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100 test - Catalog No. 665-1150; and b)…False negative results due to reagent packs exhibiting low signal. | 11/13/2007Terminated |
| Z-1158-2008 | BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 -…False negative results due to reagent packs exhibiting low signal. | 11/13/2007Terminated |
| Z-1157-2008 | BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 -…False negative results due to reagent packs exhibiting low signal. | 11/13/2007Terminated |
| Z-1156-2008 | BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450 - manufactured by…False negative results due to reagent packs exhibiting low signal. | 11/13/2007Terminated |
| Z-0575-2008 | BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic…Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment… | 11/13/2007Terminated |
| Z-0065-2008 | Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit…Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL. | 09/05/2007Terminated |
| Z-0733-2007 | Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is…The product may produce a faint line which could be interpreted as a false negative test result . | 02/12/2007Terminated |
| Z-0376-2007 | Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual…The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration… | 11/17/2006Terminated |