Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2019, with 24 FDA device recalls on record.
Top product codes for Bio-Rad Laboratories, Inc.
FDA recalls by Bio-Rad Laboratories, Inc.
10 most recent of 24- Z-2515-2025 — Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.
- Z-1572-2023 — BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
- Z-1378-2023 — BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
- Z-1377-2023 — BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
- Z-0342-2023 — CMV IgM EIA, in vitro diagnostic.
- Z-1096-2022 — BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
- Z-1208-2022 — Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
- Z-0806-2022 — BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
- Z-0807-2022 — BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
- Z-0235-2022 — BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Bio-Rad Laboratories, Inc.
- K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
- K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
- K161687 — D-10 Hemoglobin A1c Program
- K151321 — D-100 HbA1c, D-100 HbA1c Calibrator Pack
- K142448 — VARIANT II TURBO HbA1c Kit - 2.0
- K140801 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
- K130053 — BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI
- K130963 — LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
- K120504 — LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
- K120572 — BIOPLEX 2200 TORC IGG
- K120439 — BIOPLEX 2200 EBV IGG AND SYPHILIS IGG
- K092353 — MONOLISA ANTI-HAV IGM EIA
- K092355 — MONOLISA ANTI-HAV EIA
- K090699 — VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730
- K090737 — HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
- K080008 — BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
- K070452 — VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU
- K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K063400 — VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0
- K060001 — D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM
- K043341 — BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K051072 — BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
- K050682 — LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)
- K043584 — LIQUICHEK BNP CONTROL
- K041658 — BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200
- K043108 — LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
- K042446 — QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
- K042336 — METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
- K042335 — ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05
- K041444 — BIO-RAD D-10 DUAL PROGRAM
- K040822 — LIQUICHEK TORCH PLUS IGM CONTROL
- K040872 — VARIANT II HEMOGLOBIN A1C
- K040277 — LIQUICHEK CARDIAC MARKER CONTROL LT
- K040273 — LYPHOCHEK ASSAYED CHEMISTRY CONTROL
- K033924 — LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES)
- K031043 — D-10 HEMOGLOBIN A1C
- K022041 — LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
- K020817 — LIQUICHEK URINE CHEMISTRY CONTROL
- K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
- K960850 — ACCESS CHLAMYDIA ASSAY
- K963934 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
- K954687 — ACCESS RUBELLA IGG
- K960913 — ACCESS FREE T3 ASSAY
- K955769 — ACCESS PROGESTERONE ASSAY
- K955435 — ACCESS TOTAL T3 ASSAY (MODIFICATION)
- K955436 — ACCESS VITAMIN B12 ASSAY (MODIFICATION)
- K951495 — ACCESS TOXO IGG ASSAY ON THE ACCESS IMMUNOASSAY SYSTEM
- K954733 — ACCESS CORTISOL ASSAY (MODIFICATION)
- K954825 — ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K954732 — ACCESS TOTAL BHCG ASSAY (MODIFICATION)
- K953780 — ACCESS ALLERGEN DOG EPITHELIM
- K953883 — ACCESS LOW LEVEL IGE CONTROLS
- K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION)
- K951634 — ACCESS MYOGLOBIN REAGENTS
- K953084 — ACCESS ULTRASENSITIVE INSULIN ASSAY
- K950629 — ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR
- K935807 — ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
- K945083 — ACCESS CK-MB REAGENTS
- K935393 — CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
- K940833 — ACCESS(R) TOTAL T3
- K941175 — ACCESS PROLACTIN
- K940221 — ACCESS CORTISOL REAGENTS
- K940549 — ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
- K935876 — ACCESS SPECIFIC IGE ASSAY
- K940005 — ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
- K933142 — ACCESS VITAMIN B12 ASSAY
- K926475 — ACCESS(R) THYROXINE ASSAY
- K930984 — ACCESS(R) TOTAL IGE ASSAY
- K930010 — ACCESS THYROID UPTAKE ASSAY
- K926322 — ACCESS(R) CORTISOL REAGENTS
- K925637 — ACCESS HTSH ASSAY
- K923316 — EXPRESSO CARTRIDGE
- K924289 — KALLESTAD RSV MICROPLATE EIA
- K926198 — ACCESS TOTAL BHCG ASSAY
- K925913 — ACCESS(R) FREE T4 ASSAY
- K925802 — ACCESS DIGOXIN ASSAY
- K926221 — ACCESS FERRITIN ASSAY
- K924087 — KALESTAD ANA MICROPLATE EIA
- K922823 — ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS
- K915137 — KALLESTAD ROTAVIRUS MICROPLATE
- K912800 — KALLESTEAD TOTAL IGE MICROPLATE KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.