Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immu…
- Recall date
- May 30, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2515-2025
- FDA classification
- Class II
- Brand / firm
- Bio-Rad Laboratories, Inc.
- Sold / distributed
- U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Why it was recalled
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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 human serum, plasma or cord blood specimens.
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