Safety Alert: Class II: Due to a risk of false positive results that could lead to unnecessary medical treatment.
healthClass IIRecalled on Sep 10, 2025
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassa
🔢 35 kits
Sold At: Bio-Rad Laboratories, Inc.(U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.)
Recall #: FDA-DEVICE-Z-2515-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
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Summary
Due to a risk of false positive results that could lead to unnecessary medical treatment.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Bio-Rad Laboratories, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.