Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative i
Summary
The FDA issued a Class II for Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia by Bio-Rad Laboratories, Inc.. Reason: Due to a risk of false positive results that could lead to unnecessary medical treatment..
Details
Source
Device Recall
External ID
Z-2515-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054
Quantity Affected: 35 kits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-30
Company
Woodinville, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Bio-Rad Laboratories, Inc. has 12 FDA actions in our database, including 12 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bio-Rad Laboratories, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bio-Rad Laboratories, Inc. have FDA actions?
Bio-Rad Laboratories, Inc. has 12 FDA actions in our database, including 12 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2515-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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