Bio-Rad recalls Platelia Toxo IgM assay (Catalog 26211) due to potential false positive results causing unnecessary medical treatment. Affected units have UDI code 03610520005552.
Due to a risk of false positive results that could lead to unnecessary medical treatment.
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📍Recalling firmBio-Rad Laboratories, Inc.14620 Ne North Woodinville Way · Woodinville, WA 98072-8440
✎ GovInfoNow plain-language explainer
Bio-Rad is recalling its Platelia Toxo IgM assay kit (Catalog Number 26211) because it may produce false positive results. This could lead to unnecessary medical treatments for toxoplasmosis. The recall affects specific units with the UDI code 03610520005552. Read more at govinfonow.com/recall/52170-bio-rad-platelia-toxo-igm-kit-recall-risk-of-false.
“Bio-Rad Platelia Toxo IgM Kit Recall: Risk of False Positive Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52170-bio-rad-platelia-toxo-igm-kit-recall-risk-of-false. Based on FDA recall #Z-2515-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2515-2025%22&limit=1).
Bio-Rad Laboratories, Inc. recalled Platelia Toxo IgM assay kits due to a risk of false positive results that could lead to unnecessary medical treatment, the FDA said on May 30, 2025.
How to tell if you have it
Brand: Bio-Rad
Product: Platelia Toxo IgM assay
Catalog Number: 26211
UDI Code: 03610520005552
Lot Number: 4L0054
Quantity: 35 kits
Distribution: U.S. Nationwide in CA, CO, FL, NC and NV
The hazard
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. The recall addresses the risk of false positive results that could lead to unnecessary medical treatment.
Context
GovInfoNow's records show Bio-Rad Laboratories, Inc. has had 12 other recalls since April 2, 2018. Recent similar recalls include a BioPlex 220 reagent issue on Feb. 28, 2023, and a BioPlex 2200 Anti-CCP Kit false positives risk on Feb. 21, 2023. Other recent recalls of similar products include a Vivoo Protein Test recall (Nov. 22, 2025) and Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026).
How to tell if you have this one
Check for the catalog number 26211 and UDI code 03610520005552 on the kit packaging. The kit is used for detecting IgM antibodies to Toxoplasma gondii in blood samples.
Brand
Bio-Rad
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for the catalog number 26211 and UDI code 03610520005552 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Nevada, North Carolina.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2515-2025 (May 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2515-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.