Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The… — Class II medical device recall Z-2515-2025
Ongoing recall by Bio-Rad Laboratories, Inc., reported 2025-09-10, distributed nationwide. Due to a risk of false positive results that could lead to unnecessary medical treatment.
| Recall number | Z-2515-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Woodinville, WA, United States |
| Recall initiated | 2025-05-30 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 35 kits |
| UPC / GTIN / UDI-DI | 03610520005552 |
| Lot numbers | 4L0054 |
| Model numbers | 26211 |
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 for recall
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2515-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.