Bio-Rad Laboratories, Inc.: Device Recall
Recall #Z-2515-2025 · 05/30/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2515-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Bio-Rad Laboratories, Inc.
- Status
- Ongoing
- Date Initiated
- 05/30/2025
- Location
- Woodinville, WA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 kits
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 Pattern
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.