Z-2515-2025 Class II Ongoing
FDA device recall Z-2515-2025 was initiated by Bio-Rad Laboratories, Inc. on May 30, 2025 and is designated Class II. Reason for recall: Due to a risk of false positive results that could lead to unnecessary medical treatment. The recall status is ongoing. Affected quantity: 35 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- May 30, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 kits
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.
Reason for Recall
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Code Information
Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054