FDA-Device2025-09-10Class II
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.
Bio-Rad Laboratories, Inc.
Hazard
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Sold states
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
Affected count
35 kits
Manufactured in
14620 Ne North Woodinville Way, N/A, Woodinville, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief