Recall Register

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Bio-Rad Laboratories, Inc.

FDA recalling firm · 20 enforcement events · 24 product records · 2013–2025 · WA, CA

Bio-Rad Laboratories, Inc. has 20 FDA enforcement events on this register (24 product records) between 2013 and 2025: 20 device; the busiest year was 2022 with 4.

0% of its events are Class I; the most common class is Class II (17). 10 events are listed as ongoing; the recalling firm's address is in WA and CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 May 2025Platelia 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.DeviceClass II1Ongoing
28 Feb 2023BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent PackDeviceClass II1Ongoing
21 Feb 2023BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVDDeviceClass II2Ongoing
19 Oct 2022CMV IgM EIA, in vitro diagnostic.DeviceClass II1Ongoing
14 Apr 2022BioPlex 2200 REF 12000670 ToRC IgM Reagent PackDeviceClass II1Ongoing
7 Apr 2022Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000DeviceClass II1Ongoing
8 Feb 2022BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent PackDeviceClass II2Ongoing
17 Sep 2021BIO-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…DeviceClass II2Ongoing
21 Apr 2020BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum…DeviceClass II1Ongoing
1 Nov 2019BioPlex 2200 ANA Screen Control Set, REF: 663-1131 incompatible with ANA Screen Reagent Packs/ANA Kits, REF: 665-1150; and ANA Screen Calibrator Sets, REF: 663-1101DeviceClass II1Terminated
10 Jan 2019EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.DeviceClass II1Ongoing
8 Jun 2018MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.DeviceClass II2Terminated
2 Apr 2018PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human…DeviceClass II1Terminated
22 Dec 2015EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.DeviceClass II1Terminated
15 Dec 2015D-10 Rack Loader; Model Number 220-0600; 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 use of a dedicated software system for instrument control, data collection, and analysis.DeviceClass II1Terminated
13 May 2015The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.DeviceClass III1Terminated
8 Apr 2014Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and…DeviceClass II1Terminated
27 Feb 2014D-10" Hemoglobin Testing System, Model number: 220-0220 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 in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution,…DeviceClass II1Terminated
22 Nov 2013D-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 and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole…DeviceClass III1Terminated
15 Apr 2013Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.…DeviceClass III1Terminated

By type and class

Device20
Class II17
Class III3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

13
15
17
19
21
23
25
Enforcement events for Bio-Rad Laboratories, Inc. by year initiated.

Questions and answers

How many FDA recalls has Bio-Rad Laboratories, Inc. had?

20 enforcement events (24 product records) on this register, 2013–2025: 20 device.

Are any Bio-Rad Laboratories, Inc. recalls ongoing?

10 events are listed as ongoing in the current openFDA export.

What class are Bio-Rad Laboratories, Inc. recalls?

17 Class II, 3 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.