Reported Sep 10, 2025 · Ongoing

Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative…

Bio-Rad Laboratories, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bio-Rad Laboratories, Inc. · 14620 Ne North Woodinville Way · Woodinville, WA · 98072-8440

Is this the product you have?

  • Platelia
  • Toxo IgM Catalog Number 26211 UDI Code03610520005552 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
Lot codes and dates
  • Catalog Number26211
  • UDI-DI code03610520005552
  • Batch/Lot Number4L0054
Amount recalled
35 kits

Where it was sold

Why it was recalled

Due to a risk of false positive results that could lead to unnecessary medical treatment.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.