Recall Z-2515-2025— Bio-Rad Laboratories, Inc.

Name: FDA recall Z-2515-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-30

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2025-05-30. It names one FDA 510(k) clearance: K090847. 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: Due to a risk of false positive results that could lead to unnecessary medical treatment..

Recalling firm: Bio-Rad Laboratories, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-05-30
Firm location: Woodinville, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K090847 — PLATELIA TOXO IGM KIT MODEL 26211Bio-Rad Laboratories·cleared 2009-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.