Redmond, WA, United States
Bio-Rad Laboratories, Inc. recalls
14 recalls recorded since 2018, most recently on 30 May 2025. 11 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)11
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 May 2025
- Reason
- Due to a risk of false positive results that could lead to unnecessary medical treatment.
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 huma
Ongoing Class II Medical devices
- Recall started
- 15 February 2024
- Reason
- Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
- Distribution
- US Nationwide distribution in the states of PA, SD, TX, FL, MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1358-2024
- Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Ongoing Class II Medical devices
- Recall started
- 28 February 2023
- Reason
- APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CT, FL, HI, IL, IN, KS, KY, LA, MI, MO, NC, ND, NE, NJ, NM, NY, OH, OK, PR,SC, TN, TX, UT, VT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1572-2023
- BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Ongoing Class II Medical devices
- Recall started
- 21 February 2023
- Reason
- Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1378-2023, Z-1377-2023
- BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
- BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Ongoing Class II Medical devices
- Recall started
- 19 October 2022
- Reason
- Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
- Distribution
- U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0342-2023
- CMV IgM EIA, in vitro diagnostic.
Ongoing Class II Medical devices
- Recall started
- 14 April 2022
- Reason
- Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ, CA, FL, HI, IA, IL, MI, MN, NE, NY, TN, TX, and WA. The countries of Czech Republic, France, Germany, and Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1096-2022
- BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Ongoing Class II Medical devices
- Recall started
- 7 April 2022
- Reason
- The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. 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 Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CD¿ROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.
- Distribution
- US: AZ, AR, GA, CO, TN, LA, VA, FL, KY, IN, KS, MD, MN, MO, NC, NJ, NY, OH, OR, SC, IA, AL, UT, PR OUS: Canada, Spain, France, Italy, India, Vietnam, Philippines
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1208-2022
- Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000
Ongoing Class II Medical devices
- Recall started
- 8 February 2022
- Reason
- Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioPlex 2200 Syphilis Total & RPR panel, as well as intermittent manufacturing challenges to produce RPR reagents that consistently meet stability specifications
- Distribution
- Worldwide distribution U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The countries of France, Germany, Italy, Spain, Sa
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0806-2022, Z-0807-2022
- BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack
- BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL
Ongoing Class II Medical devices
- Recall started
- 17 September 2021
- Reason
- Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and 2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.
- Distribution
- Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0236-2022, Z-0235-2022
- BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.
- 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 t
Ongoing Class II Medical devices
- Recall started
- 21 April 2020
- Reason
- The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), Fr
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2982-2020
- BioPlex 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 q
Terminated Class II Medical devices
- Recall started
- 1 November 2019
- Terminated
- 27 September 2023
- Reason
- A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs.
- Distribution
- Worldwide distribution - U.S Nationwide distribution including in the states of CA, FL, NJ, IL, NE, TN, IN, TX, LA, WA, MI, MA, MN, OH, HI, MO, PA, CT, UT, SD, NY, AL, PR, OR, MD, KY, NC, AZ, SC, VA, WI, GA, IA, RI, AK, OK, KS, ND, MS, ME, NM, AR and the countries of ES, AE, DE, FR, KR, CN, TW, JP,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0082-2022
- BioPlex 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: 663-1101
Ongoing Class II Medical devices
- Recall started
- 10 January 2019
- Reason
- User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
- Distribution
- Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1906-2019
- EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Terminated Class II Medical devices
- Recall started
- 8 June 2018
- Terminated
- 30 October 2020
- Reason
- Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies.
- Distribution
- US Nationwide Distribution to: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1742-2019, Z-1743-2019
- MRSASelect, 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 MR
- MRSASelect II, IVD, REF 63758 (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 fro
Terminated Class II Medical devices
- Recall started
- 2 April 2018
- Reason
- The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
- Distribution
- US Nationwide Distribution inn the states of : AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2541-2018
- PR4100 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 instru
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.