FDAHealthMay 30, 2025
Bio-Rad Laboratories, Inc. — Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detecti
⚠️ Due to a risk of false positive results that could lead to unnecessary medical treatment.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 30, 2025
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
What's affected?
- 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.
- Lot code
- 4L0054
Additional details
Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 35 kits.
Get Health recall alerts
Delivered to your inbox. Free. No account required.