Toxoplasma IgM assay kits recalled over risk of false positive results
Platelia Toxo IgM kits, catalog number 26211, lot 4L0054, are recalled because of a risk of false positive results that could lead to unnecessary medical treatment. 35 kits are affected.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice states false positives could lead to unnecessary medical treatment and reports no injuries.
Plain-English summary
The Platelia Toxo IgM assay, catalog number 26211, UDI code 03610520005552, batch/lot 4L0054, is being recalled. The kit is a semi-quantitative immunocapture enzyme immunoassay for detecting IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood. The recall covers 35 kits distributed in California, Colorado, Florida, North Carolina and Nevada.
The recall was issued because of a risk of false positive results that could lead to unnecessary medical treatment. The FDA classified the action as Class II.
Laboratories holding this lot should stop using it and follow the manufacturer's instructions on affected kits and on results already reported.
The recalled product
- 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.
- Manufacturer
- Bio-Rad Laboratories, Inc.
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
Distribution
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