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.
Reported: September 10, 2025 Initiated: May 30, 2025 #Z-2515-2025
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.
Details
- Recalling Firm
- Bio-Rad Laboratories, Inc.
- Units Affected
- 35 kits
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
- Location
- Woodinville, WA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bio-Rad Laboratories, Inc.. Units affected: 35 kits.
Why was this product recalled? ▼
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2515-2025.
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