BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-2515-2025 · Reported September 10, 2025

    Enforcement

    Recall Number
    Z-2515-2025
    Event ID
    97106
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2025
    Initiation Date
    May 30, 2025
    Classification Date
    September 4, 2025
    Address
    14620 Ne North Woodinville Way, N/A, Woodinville, WA, 98072-8440, United States

    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.

    Reason

    Due to a risk of false positive results that could lead to unnecessary medical treatment.

    Code Info

    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.

    Quantity

    35 kits