Device 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.
Z-2515-2025
Product summary
- Event
- Event 97106
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 35 kits
- Official record key
device-enforcement:Z-2515-2025
Official wording
Reason: Due to a risk of false positive results that could lead to unnecessary medical treatment.
Code information: Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
Distribution pattern: U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Derived failure modes
-
Unknown
Due to a risk of false positive results that could lead to unnecessary medical treatment.