Recall Register

Bio-Rad Laboratories, Inc.: FDA recalls

FDA enforcement events from 2013 to 2025; export dated . The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Bio-Rad Laboratories, Inc. as the recalling firm in 20 events. The events have 24 product records. The recalls started from 2013 to 2025. All the events are device recalls. By FDA enforcement events, Bio-Rad Laboratories, Inc. is number 175 of 1,628 firms that have a page. Events that Bio-Rad Laboratories, Inc. started: none in 2024 and 1 in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 85.0% of its events and 73.7% of all FDA events.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

20 events, newest first.

FDA enforcement events of Bio-Rad Laboratories, Inc.
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

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Bio-Rad Laboratories, Inc.: events for each product type
TypeEvents
Device20
Bio-Rad Laboratories, Inc.: events in each class
ClassEvents
Class II17
Class III3
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
10

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Bio-Rad Laboratories, Inc., by the year that the recall started. The largest year is 2022, with 4 events.

Official channels

Cite this page

Recall Register. Bio-Rad Laboratories, Inc.: FDA recalls. https://recallregister.com/firm/bio-rad-laboratories-inc/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
3 Nov 2026
State of the firm address
WA, CA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Bio-Rad Laboratories, Inc. have?
Class II: 17 events. Class III: 3 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Bio-Rad Laboratories, Inc.?
FDA event 97106, which the firm started on 30 May 2025. The first product in the record is: 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.
How many FDA recalls of Bio-Rad Laboratories, Inc. have the status Ongoing?
10 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.