BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 30, 2025

    Recall

    Recall Number
    Z-2515-2025
    Event Number
    97106
    Firm
    Bio-Rad Laboratories, Inc.
    FEI Number
    3002701146
    Product Code
    LGD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    May 30, 2025
    Posted
    September 4, 2025
    Address
    14620 Ne, North Woodinville Way Woodinville, WA, 98072-8440

    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.

    Action

    On 05/30/2025, the firm sent via email an "URGENT MEDICAL DEVICE NOTIFICATION" to customers informing them that, as a result of an internal investigation, it was revealed that samples taken from a frozen negative control panel tested unexpectedly interpreted as equivocal or positive results. Customer are instructed to: . As the issue can alter product performance of the affected lots by reducing specificity and increasing the number of equivocal results, interpret positive results with caution and contact Bio-Rad Technical Support if you observe an unusual rate of false positive results. . Refer to the test limitations, as outlined in Section 9 Limitations of the Procedure, of the IFU 0002043 version 2023/11: Diagnosis of recent infection by T. gondii can only be established on the basis of a combination of clinical and serological data. The result of a single serum sample does not constitute sufficient proof for diagnosis of recent infection . . As noted in Section 8 Interpretation of Results, positive IgM results should be followed by confirmatory steps in accordance with CDC guidelines before initiating or continuing treatment. For questions or assistance, contact Bio-Rad Technical Support at 1-800-224-6723 or by email at [email protected]

    Distribution

    U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.

    Quantity

    35 kits