Food, drugs, devices › Bio-Rad Laboratories, Inc.
Device recall: Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immun
Bio-Rad Laboratories, Inc. (Woodinville, WA) initiated this device recall on 30 May 2025; FDA lists 1 product record under event 97106, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Bio-Rad Laboratories, Inc. has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bio-Rad Laboratories, Inc., Woodinville, WA.
Reason for recall
"Due to a risk of false positive results that could lead to unnecessary medical treatment."
Distribution
"U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2515-2025 | 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. | 35 kits | Class II | Ongoing | 10 Sep 2025 |
Context
Other enforcement events for Bio-Rad Laboratories, Inc.
All 20 events for Bio-Rad Laboratories, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to a risk of false positive results that could lead to unnecessary medical treatment."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.