Z-2515-2025 Class II Ongoing

Recalled by Bio-Rad Laboratories, Inc. — Woodinville, WA

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