Medical device recalls Moderate risk

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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