Medical Device Recall: 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 Toxop
Bio-Rad Laboratories, Inc. · May 30, 2025
Reason for Recall
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Product Description
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.
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
States Affected
NATIONWIDE
Quantity Affected
35 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2515-2025
Status: ongoing
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