Platelia Toxo IgM recall
Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay…
Why was Platelia Toxo IgM recalled?
Due to a risk of false positive results that could lead to unnecessary medical treatment.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
- Product
- Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay…
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Quantity
- 35 kits
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
- Recall date
- September 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)