Bio-Rad Laboratories, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2515-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 30, 2025

Date Posted: September 10, 2025

Recall Number: Z-2515-2025

Event ID: 97106

Reason for Recall:

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

Status: Ongoing

Product Quantity: 35 kits

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.

Voluntary or Mandated:

Voluntary: Firm initiated