FDA Medical devices recall ·
Platelia Toxo IgM recall
- Recall number
- Z-2515-2025
- Date
- (initiated May 30, 2025)
- Company / brand
- Bio-Rad Laboratories, Inc.
14620 Ne North Woodinville Way, Woodinville, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 35 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to a risk of false positive results that could lead to unnecessary medical treatment.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.
States: California Colorado Florida North Carolina Nevada
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2515-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.