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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Bio-Rad Platelia Toxo IgM Assay Kits Recalled for False Positive Risk

Agency Publication Date: September 4, 2025
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Summary

Bio-Rad Laboratories, Inc. has recalled 35 Platelia Toxo IgM assay kits (Catalog Number 26211) due to a defect that can cause false positive test results. These kits are used in laboratories to detect antibodies to Toxoplasma gondii in human blood specimens. A false positive result could lead to patients receiving medical treatment that they do not actually require. No injuries or incidents have been reported to date.

Risk

The assay may incorrectly indicate the presence of Toxoplasma gondii antibodies when they are not actually present. This false positive result could lead to unnecessary or incorrect medical interventions and treatments for the patient.

What You Should Do

  1. This recall affects Bio-Rad Platelia Toxo IgM assay kits, which are used to detect Toxoplasma gondii in human serum, plasma, or cord blood specimens.
  2. Identify affected products by checking for Catalog Number 26211, UDI-DI code 03610520005552, and Batch/Lot Number 4L0054 on the kit packaging.
  3. Stop using the recalled product immediately.
  4. Contact Bio-Rad Laboratories, Inc. or your laboratory's distributor to arrange for the return, replacement, or correction of the assay kits.
  5. If you have additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Platelia Toxo IgM Assay Kit
Model / REF:
26211
Lot Numbers:
4L0054
UDI:
03610520005552

The kit is a semi-quantitative immunocapture enzyme immunoassay.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97106
Status: Active
Manufacturer: Bio-Rad Laboratories, Inc.
Sold By: Bio-Rad Laboratories, Inc.
Manufactured In: United States
Units Affected: 35 kits
Distributed To: California, Colorado, Florida, North Carolina, Nevada

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.