Home / Recalls / Medical Devices
Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative i
Recalled September 10, 2025 · FDA recall Z-2515-2025 · Bio-Rad Laboratories
Hazard
Due to a risk of false positive results that could lead to unnecessary medical treatment. · FDA Class II
Units
35 kits
Sold at
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Description
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Product
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.
Manufacturer(s)
Bio-Rad Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →