Platelia Toxo IgM immunoassay kit recalled for risk of false positives
Bio-Rad is recalling Platelia Toxo IgM immunoassay kits due to a risk of false positive results that could lead to unnecessary medical treatment.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—false positive test results—is theoretical in nature. Per FDA severity criteria, recalls with theoretical hazards and no reported clinical impact fall under Moderate severity.
Plain-English summary
Bio-Rad Laboratories, Inc. is recalling the Platelia Toxo IgM immunoassay kit (Catalog Number 26211, UDI Code 03610520005552, Lot 4L0054). The kit is a semi-quantitative immunoassay used to detect IgM antibodies to Toxoplasma gondii in human serum, plasma, or cord blood specimens.
The recall is due to a risk of false positive results in the assay, which could lead to unnecessary medical treatment.
The affected kits were distributed nationwide in California, Colorado, Florida, North Carolina, and Nevada. Customers who have received this product should contact Bio-Rad Laboratories, Inc. for further information regarding the recall.
The recalled product
- 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
- Bio-Rad Laboratories, Inc.
- Category
- Medical Device
- Hazard
- false-positive-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
Distribution
Distributed nationwide across the United States.
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