FDA recall Z-2515-2025

Bio-Rad Laboratories, Inc. · Class II · 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.

Reason for recall

Due to a risk of false positive results that could lead to unnecessary medical treatment.

Distribution

U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.

Key facts

Status
Ongoing
Initiation date
2025-05-30
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Woodinville, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2025