--- title: "Bio-Rad Laboratories, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Bio-Rad Laboratories, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/bio-rad-laboratories-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Bio-Rad Laboratories, Inc. recall records **9** reported ongoing 9 records in this archive. Latest source date May 30, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 30, 2025 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-2515-2025-platelia-toxo-igm-catalog-number-26211-udi-code-03610520005552-the-platelia-toxo-igm-assay-is-a-semi/) Due to a risk of false positive results that could lead to unnecessary medical treatment. Class II Reported ongoing Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV. [Official source for Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2515-2025%22) Feb 28, 2023 FDA device enforcement ### [BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack](https://isitonrecall.com/recall/fda-device-z-1572-2023-bioplex-2200-ref-665-2050-apls-igm-pack-apls-igm-reagent-pack/) APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. Class II Reported ongoing 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. [Official source for BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1572-2023%22) Feb 21, 2023 FDA device enforcement ### [BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD](https://isitonrecall.com/recall/fda-device-z-1377-2023-bioplex-2200-anti-ccp-reagent-pack-ref-665-3250-ivd/) 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... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden. [Official source for BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1377-2023%22) Feb 21, 2023 FDA device enforcement ### [BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD](https://isitonrecall.com/recall/fda-device-z-1378-2023-bioplex-2200-anti-ccp-calibrator-set-ref-663-3200-ivd/) 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... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden. [Official source for BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1378-2023%22) Oct 19, 2022 FDA device enforcement ### [CMV IgM EIA, in vitro diagnostic.](https://isitonrecall.com/recall/fda-device-z-0342-2023-cmv-igm-eia-in-vitro-diagnostic/) Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). Class II Reported ongoing Distribution: U.S.: CA, CO, FL, GA, HI, IA, MA, MN, NC, NH, NJ, PA, TN, and TX O.U.S.: None [Official source for CMV IgM EIA, in vitro diagnostic.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0342-2023%22) Apr 14, 2022 FDA device enforcement ### [BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack](https://isitonrecall.com/recall/fda-device-z-1096-2022-bioplex-2200-ref-12000670-torc-igm-reagent-pack/) Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack. Class II Reported ongoing 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, Germa... [Official source for BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1096-2022%22) Apr 7, 2022 FDA device enforcement ### [Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000](https://isitonrecall.com/recall/fda-device-z-1208-2022-resin-update-cd-rom-ref-250-3020-inside-variantnbs-sickle-cell-program-reorder-pack-ref-250-3000/) 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 Cel... Class II Reported ongoing 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 [Official source for Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1208-2022%22) Feb 8, 2022 FDA device enforcement ### [BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack](https://isitonrecall.com/recall/fda-device-z-0806-2022-bioplex-2200-ref-12000650-syph-t-pack-syphilis-total-rpr-reagent-pack/) 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 Class II Reported ongoing 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, ... [Official source for BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0806-2022%22) Feb 8, 2022 FDA device enforcement ### [BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL](https://isitonrecall.com/recall/fda-device-z-0807-2022-bioplex-2200-ref-12000651-syphilis-total-rpr-calibrator-set-cal/) 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 Class II Reported ongoing 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, ... [Official source for BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0807-2022%22) ## Reasons in these listed records - Due to a risk of false positive results that could lead to unnecessary medical treatment. - APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. - 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... - 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... These examples come from this result page and are not a ranking of every recall reason. ## Checking Bio-Rad Laboratories, Inc. ### Is there a recall on bio-rad laboratories, inc. right now? This archive contains 9 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Bio-Rad Laboratories, Inc.](https://isitonrecall.com/check/?q=Bio-Rad%20Laboratories%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)