Data / Medical devices / United States / Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc.: FDA-registered device maker in Hercules, CA, United States, 82 510(k) clearances
Bio-Rad Laboratories, Inc. is registered with the FDA (registration 2915274) in Hercules, CA, United States. It lists 73 device types. The FDA files 82 510(k) clearances under its listings, the newest dated March 12, 2019. 40 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2915274
- Address
- 4000 Alfred Nobel Drive, Hercules, CA, United States, 94547
- Owner or operator
- Bio-Rad Laboratories, Inc. (9929003)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 31, 1977
- Registered through
- 2026
- Brand names listed
- ANA Screen with MDSS, Accessory Component for the PhD lx IFA/ EIA Processing and PhD Testing Sytems, Autoimmune EIA ANA Screening Test Kit (576 Test), Autoimmune EIA ANA Screening Test Kit (96 Test), Autoimmune EIA ANA-6 Profile, Autoimmune EIA Anti-Centromere, Autoimmune EIA Anti-Jo-1, Autoimmune EIA Anti-SS-A/Ro and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2019 | K183446 | BioPlex 2200 Lyme Total | LSR | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| February 13, 2019 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | OYX | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180577 | BioPlex 2200 25-OH Vitamin D Kit | MRG | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| September 13, 2017 | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | GKA | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 19, 2017 | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | PUQ | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| May 11, 2017 | K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | LIP | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| October 14, 2016 | K161687 | D-10 Hemoglobin A1c Program | PDJ | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| December 9, 2015 | K151321 | D-100 HbA1c, D-100 HbA1c Calibrator Pack | PDJ | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| March 24, 2015 | K142448 | VARIANT II TURBO HbA1c Kit - 2.0 | PDJ | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| January 9, 2015 | K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | MRG | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| June 25, 2014 | K140801 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| December 5, 2013 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | MST | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| October 21, 2013 | K130528 | BIOPLEX 2200 APLS IGM | MID | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| September 19, 2013 | K130053 | BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI | MVM | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 9, 2013 | K130990 | VARIANT(TM) II TURBO HBA1C KIT - 2.0 | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc., Clinical Systems Divis | accessdata.fda.gov |
| April 25, 2013 | K130860 | VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc., Clinical Systems Divis | accessdata.fda.gov |
| November 2, 2012 | K123021 | BIOPLEX 2200 EBV IGM KIT | LJN | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| October 26, 2012 | K122472 | VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc., Clinical Systems Divis | accessdata.fda.gov |
| July 9, 2012 | K113610 | ANA-SCREEN WITH MDSS | LKJ | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| June 22, 2012 | K120959 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT | MXJ | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 30, 2012 | K103834 | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | MID | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 26, 2012 | K120572 | BIOPLEX 2200 TORC IGG | OMI | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| October 26, 2011 | K112810 | MULTI-ANALYTE DETECTION SYSTEMS | NHX | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| August 23, 2011 | K111072 | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL | OPL | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| August 24, 2010 | K093954 | BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | NHX | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| March 29, 2010 | K091616 | BIOPLEX 2200 MMRV IGG | OPL | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| July 27, 2009 | K090699 | VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| June 3, 2009 | K090737 | HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI | JKA | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 8, 2009 | K090409 | BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | MXJ | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| February 23, 2009 | K080008 | BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET | OMI | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 2, 2008 | K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH | GKA | Substantially Equivalent | Bio-Rad Laboratories Inc., Clinical Systems Divisi | accessdata.fda.gov |
| October 31, 2007 | K072358 | BIOPLEX VASCULITIS KIT | MVJ | Substantially Equivalent | Bio-Rad Laboratories | accessdata.fda.gov |
| June 25, 2007 | K070819 | VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, | LCP | Substantially Equivalent | Bio-Rad Laboratories Inc., Clinical Systems Divisi | accessdata.fda.gov |
| May 7, 2007 | K070452 | VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| December 27, 2006 | K063643 | MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM | LCP | Substantially Equivalent | Bio-Rad Laboratories Inc., Clinical Systems Divisi | accessdata.fda.gov |
| December 8, 2006 | K062213 | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | LSE | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| December 8, 2006 | K062211 | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | LSE | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| December 4, 2006 | K062045 | EDIA ANTI-CCP | NHX | Substantially Equivalent | Euro-Diagnostica AB | accessdata.fda.gov |
| December 1, 2006 | K063400 | VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| November 13, 2006 | K061718 | INNOVACON SPECTRUM II TEST CARD | DKZ | Substantially Equivalent | Innovacon, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060466 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 27, 2005 | K043341 | BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | NVI | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 12, 2005 | K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | GKA | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| February 25, 2005 | K043507 | ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 20, 2004 | K041658 | BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 | LKJ | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| June 9, 2004 | K041444 | BIO-RAD D-10 DUAL PROGRAM | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| May 19, 2004 | K040445 | ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE | JXN | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| April 15, 2004 | K040872 | VARIANT II HEMOGLOBIN A1C | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| August 27, 2003 | K031043 | D-10 HEMOGLOBIN A1C | LCP | Substantially Equivalent | Bio-Rad Laboratories, Inc. | accessdata.fda.gov |
| October 28, 2002 | K022589 | ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 17, 2002 | K021526 | ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE | LFG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| December 18, 2001 | K013380 | ACON MOP ONE STEP OPIATE TEST STRIP, ACON MOP STEP OPIATE TEST DEVICE | DJG | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| November 9, 2001 | K012824 | ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE | DIS | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| October 15, 2001 | K012595 | ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE | DJR | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| September 17, 2001 | K012300 | ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE | JXM | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| August 9, 2001 | K011730 | ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE | LCM | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 31, 2001 | K011673 | ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE | DKZ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 31, 2001 | K011672 | ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE | LAF | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| July 9, 2001 | K010841 | ACON COC ONE STEP COCAINE TEST STRIP, ACON COC ONE STEP COCAINE TEST DEVICE | DIO | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| March 15, 2001 | K003557 | ACON THC ONE STEP MARIJUANA TEST STRIP(URINE);ACON THC ONE STEP MARIJUANA TEST DEVICE (URINE) | LDJ | Substantially Equivalent | ACON Laboratories, Inc. | accessdata.fda.gov |
| April 5, 2000 | K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | LLL | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| June 10, 1999 | K991127 | VARIANT II B-THALASSEMIA | JPD | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| November 30, 1998 | K982898 | IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM | MOB | Substantially Equivalent | Immco Diagnostics, Inc. | accessdata.fda.gov |
| March 20, 1996 | K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | LRM | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| December 15, 1995 | K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| August 24, 1995 | K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | LLL | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| July 18, 1995 | K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | LJM | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| July 17, 1995 | K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | LJM | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| June 30, 1995 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | Substantially Equivalent | Shield Diagnostics, Ltd. | accessdata.fda.gov |
| November 10, 1994 | K942451 | BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM | LDM | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| April 20, 1994 | K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | LKO | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| April 20, 1994 | K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | LKP | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| August 5, 1993 | K932419 | ANTI-SS-B/LA ANTIBODY TEST | LLL | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| July 16, 1993 | K931495 | ENZYME IMMUNOASSAY ANTI-SS-A/RO ANTIBODY TEST KIT | LLL | Substantially Equivalent | Helix Diagnostics, Inc. | accessdata.fda.gov |
| December 13, 1990 | K905386 | DISTAT ANTI-DSDNA KIT | KTL | Substantially Equivalent | Shield Diagnostics, Ltd. | accessdata.fda.gov |
| October 25, 1989 | K894966 | PLASMA CATECHOLAMINES BY HPLC | CHQ | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| March 21, 1989 | K890768 | PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT | LYF | Substantially Equivalent | Genetic Systems Corp. | accessdata.fda.gov |
| May 1, 1986 | K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | CDF | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 22, 1985 | K852237 | LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT | LHL | Substantially Equivalent | Genetic Systems Corp. | accessdata.fda.gov |
| January 18, 1982 | K813592 | QUANTAFLUOR FLUORESCENT TEST REAGENTS | DHN | Substantially Equivalent | Kallestad Laboratories, Inc. | accessdata.fda.gov |
| April 14, 1981 | K810863 | KALLESTAD HEP-2 CELL LINE SUBSTRATE | DBM | Substantially Equivalent | Kallestad Laboratories, Inc. | accessdata.fda.gov |
| September 7, 1978 | K780899 | FLUORESCENT ANTI-NATIVE DNA TEST | DHN | Substantially Equivalent | Kallestad Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 7, 2022 | 90027 | Class II | Ongoing | Resin UPDATE CD-ROM, REF: inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: | The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number:, included in VARIANT nbs Sickle Cell Progam Reorder Pack #. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setti | accessdata.fda.gov |
| December 15, 2015 | 72927 | Class II | Terminated | D-10 Rack Loader; Model Number; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the | On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration. | accessdata.fda.gov |
| April 8, 2014 | 68016 | Class II | Terminated | Variant II beta-thalassemia Short Program Model Numbers (250 tests) and (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used. | accessdata.fda.gov |
| February 27, 2014 | 67624 | Class II | Terminated | D-10" Hemoglobin Testing System, Model number: Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis | On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample. | accessdata.fda.gov |
| November 22, 2013 | 66947 | Class III | Terminated | D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation | D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System. | accessdata.fda.gov |
| October 25, 2011 | 60230 | Not yet classified | Terminated | VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human whole blood. Contents: Elution Buffer A, 1 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solut | It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point. | accessdata.fda.gov |
| September 12, 2011 | 59868 | Not yet classified | Terminated | D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml B | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented. | accessdata.fda.gov |
| July 28, 2011 | 59659 | Not yet classified | Terminated | VARIANT II TURBO Link Hemoglobin A1c Program Reorder Pack. Calibrator/Diluent Set. IVD. Kit components: Elution Buffer A, 2 x 2500 mL Elution Buffer B, 1 x 2100 mL Wash/Diluent Solution, 1 x 2500 mL Cartridge Set, 2 Cati | The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. | accessdata.fda.gov |
| July 11, 2011 | 59346 | Not yet classified | Terminated | D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. Bio-Rad Laboratories Inc. Hercules, CA. Product Usage: Short Proghram: D-10 Dual Program | Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435. | accessdata.fda.gov |
| January 20, 2011 | 57778 | Not yet classified | Terminated | PhD System EIA/IFA Software; Model/Catalog Number:; The Bio-Rad PhD System is an EIA and IFA processing system that consists of a PhD fluid handling station(s) linked to a network computer via an Ethernet hub. The networ | Firm's Correction involves advising customers who have implemented a Laboratory Information System (LIS) that they need to ensure quantitative results have passed all validation criteria prior to reporting patient results. When a patient result fails a Validation Rule, the qualitative result will indicate "INVALID". | accessdata.fda.gov |
| September 8, 2010 | 56807 | Not yet classified | Terminated | Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: (Reorder Pack); (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., | The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704. | accessdata.fda.gov |
| September 7, 2010 | 56762 | Not yet classified | Terminated | in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and in2it (II) A1c Test Cartridges (Catalog ), manufactured by Bio-Rad Laboratories Deeside Ltd., Flintshire, UK, distributed by Bio-Rad Laboratories, Hercules, CA. The | Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results. | accessdata.fda.gov |
| July 26, 2010 | 56503 | Not yet classified | Terminated | in2it (I) and (II) System A1c Test cartridges and in2it Self Test System A1c Test Cartridges, for use with the in2it (I) and (II) self test system analyzer, manufactured by Bio-Rad, Flintshire, UK The in2it (I) and (II) | Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes. | accessdata.fda.gov |
| June 24, 2010 | 56126 | Not yet classified | Terminated | Bio-Rad Laboratories Autoimmune EIA ANA Screening kit, 96 test, model 96AN, Distributed and Manufactured by Bio-Rad Laboratories, Inc. | Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because controls will not pass.. | accessdata.fda.gov |
| April 22, 2010 | 55905 | Not yet classified | Terminated | The VARIANT Sickle Cell Short Program ROM Card; Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The VARIANT Sickle Cell Short Program is designed as a qualitative screen for the presence of he | The presence of parameters for Version 40400-S on the labeled VARIANT Sickle Cell Short ROM Card instead of Version 80300-S. | accessdata.fda.gov |
| April 14, 2010 | 55910 | Not yet classified | Terminated | VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:, included in; Distributed and Manufactured by Bio-Rad Laboratories, Inc. The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the prese | The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed. | accessdata.fda.gov |
| March 24, 2010 | 56387 | Not yet classified | Terminated | Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.:, which contains the update kit CD-ROM, Model/Catalog No.:, Distributed and Manufactured by: Bio-Rad Laboratories, Inc., Hercul | The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated. | accessdata.fda.gov |
| March 2, 2010 | 56044 | Not yet classified | Terminated | Bio Rad brand Autoimmune EIA Anti-dsDNA Test Kit, 96 Tests, Catalog No. 96DS, Distributed by and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Bio-Rad Autoimmune EIA Anti-dsDNA Test is a qualitative enzyme | The firm received customer complaints of increased positivity rates associated with the Anti-dsDNA test kits. | accessdata.fda.gov |
| March 1, 2010 | 56385 | Not yet classified | Terminated | Bio Rad brand Autoimmune EIA ANA Screening Kit, 96 Tests, Catalog No. 96AN-BPU-TRINITY. Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Trinity Biotech, USA. Intended to screen for the presenc | The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability. | accessdata.fda.gov |
| March 1, 2010 | 56047 | Not yet classified | Terminated | Autoimmune EIA ANA Screening Test Kit, 96 Tests, Model/Catalog Number: 96AN manufactured by Bio-Rad, Hercules, CA | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. | accessdata.fda.gov |
| March 1, 2010 | 55293 | Not yet classified | Terminated | DiaSorin ETI-ANA Screen Kit, 96 Test, Model Number N0093, manufactured by Bio-Rad Laboratories. | Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. | accessdata.fda.gov |
| February 26, 2010 | 55815 | Not yet classified | Terminated | Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzy | The value for the ANA Cutoff and ANA Positive Controls will decrease overtime resulting in an unusually elevated positivity rate for patient samples tested. | accessdata.fda.gov |
| February 24, 2010 | 56386 | Not yet classified | Terminated | Bio-Rad brand Meridian ANA Screen ELISA Test Kit, 96 Test, Catalog No. 4884261, Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA and distributed by Meridian Diagnostics. | False positive test results caused by decrease in the OD values of ANA Cutoff Controls and ANA Positive Controls. The increased positivity rates were associated with the Meridian ANA Screening kit. False positive ANA values could result in misdiagnosis or mistreatment. | accessdata.fda.gov |
| February 19, 2010 | 54746 | Not yet classified | Terminated | Bio-Rad Variant II Turbo Link Hemoglobin Testing System, including Hemoglobin A, Program Reorder Pack 1600 Tests, Program Buffer A, Buffer B, Cartridge Set, Analytical Cartridge, Guard Cartridge, Calibrator, Accessory Bo | The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results. | accessdata.fda.gov |
| January 26, 2010 | 54551 | Not yet classified | Terminated | Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number, included in, and, Manufactured by Bio-Rad Laboratories, Hercules, CA | Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury. | accessdata.fda.gov |
| December 8, 2009 | 54684 | Not yet classified | Terminated | Device brochure, labeled in part : BIO -RAD***L70242709 VARIANT TM II TURBO***Hemoglobin A 1C***Cartridge Set, Cartridge Set, Analytical Cartridge, Guard Cartridge Insert***UNITED STATES, Bio-Rad Laboratories, Inc. Hercu | Wrong lot number was found on the Hemoglobin Cartridge Insert. The insert did not match the lot number to the device cartridge or the device cartridge label or on the Update Kit CD. | accessdata.fda.gov |
| December 1, 2009 | 54483 | Not yet classified | Terminated | Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: and; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Intended Use is as follows: Th | Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results. | accessdata.fda.gov |
| October 12, 2009 | 53649 | Not yet classified | Terminated | Variant II Turbo Hemoglobin A1c Program, model number, manufactured by Bio-Rad Laboratories, Inc, Hercules, CA. Intended Use: For the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-p | Product update kit CD rom will not upload. As a result, the device cannot be run. | accessdata.fda.gov |
| September 29, 2009 | 53690 | Not yet classified | Terminated | PhD System EIA/IFAversion 2.1A software, model number, a component of the Bio-Rad PhD System. Manufactured by Bio-Rad Laboratories, France, Distributed by Bio-Rad Laboratories, Hercules, CA. EIA and IFA processing system | Incorrect patient results are being generated from out-of-range samples tested withc ompetitive enzyme immunoassays on the PhD system with software version 2.1A. | accessdata.fda.gov |
| July 14, 2009 | 52889 | Not yet classified | Terminated | BIO-RAD Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16...Lot CL-863. Positive Control included in lot is identified as "REF " and "LOT CPM-591". in vitro diagnostic. | The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863. | accessdata.fda.gov |
| June 15, 2009 | 52719 | Not yet classified | Terminated | Bio-Rad VARIANT II Hemoglobin A1c Program Recorder Pack with Calibrator/Diluent Set, Model Number 270-2101NU Manufactured by Bio-Rad Laboratories, Hercules, CA | Calibration Failure-- due to high intercept values, the device fails calibration and users are unable to run samples. | accessdata.fda.gov |
| January 22, 2009 | 51498 | Not yet classified | Terminated | VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number:; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Provides an integrated method for s | Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position. | accessdata.fda.gov |
| December 9, 2008 | 50531 | Not yet classified | Terminated | Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0, model number, Manufactured by Bio-Rad Laboratories, Hercules, CA Measurement of percent hemoglobin Alc is effective in monitoring long-term glucose control in | The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results. | accessdata.fda.gov |
| October 17, 2008 | 50174 | Not yet classified | Terminated | Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number, Manufactured by Bio-Rad Laboratories, Hercules, CA Provides an integrated method for sample preparation, separation and the percent determi | Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results. | accessdata.fda.gov |
| March 18, 2008 | 47421 | Not yet classified | Terminated | VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number (250 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104 | Some product ROM cards have an incorrect program loaded and are unable to be updated. | accessdata.fda.gov |
| November 13, 2007 | 45892 | Not yet classified | Terminated | BioRad BioPlex 2200 Software, for BioPlex 2200 Instrument, an automated immunodiagnostic analyzer, Bio-Rad Laboratories, Inc., Hercules, CA 94547 | Incorrect values: An error was found in the BioPlex 2200 Software, Version 2.0 that results in assignment values being utilized for the BioPlex assay Calibrator Set that may be slightly different from those printed on the Value Assignment Data Sheet. Some values may be identical between the lot assignment combinations with the ANA Screen with MDSS kit. | accessdata.fda.gov |
| September 25, 2007 | 45332 | Not yet classified | Terminated | BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU Packet contains the Syphilis IgG Assay Protocol File LAPF CD | Mislabeling: Reporting terminology in the Syphilis IgG APF CD is not consistent with the distributed Instructions for Use. (Non-Reactive and Reactive rather than Negative and Positive) | accessdata.fda.gov |
| February 12, 2007 | 37465 | Not yet classified | Terminated | Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA | The product may produce a faint line which could be interpreted as a false negative test result. | accessdata.fda.gov |
| November 17, 2006 | 37097 | Not yet classified | Terminated | Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a specific part of the kit, and only the calibrator diluent is defective. It comes in two kits. | The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results. | accessdata.fda.gov |
| June 4, 2004 | 34055 | Not yet classified | Terminated | Bio-Rad brand ''TOX/See Drug Screen Test''; Catalog numbers: 1945182EX, 1945216 | The device was producing false negative results for cocaine tests. | accessdata.fda.gov |
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Updated March 12, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.