BEUDAMED
    FDA Recall Terminated

    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number

    Recall: Z-1058-2022 · Initiated April 17, 2022

    Recall

    Recall Number
    Z-1058-2022
    Event Number
    90107
    FEI Number
    3012671593
    Product Code
    QKO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2022
    Terminated
    January 23, 2024
    Address
    PROTERIXBIO 1 Fortune Dr, Billerica, MA, 01821-3923

    Description

    ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number

    Reason

    FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or false negatives).

    Action

    On April 17, 2022, the firm notified affected physicians who had ordered tests and received results since September 2020 via email. Customers were informed that the prior test results may not have been accurate. In addition, customers were instructed to check their stock and destroy any remaining Dried Blood Spot Collection Kits (ProterixBio SARS-CoV-2 RBD Antibody Test sampling kits). Customers should note the number of kits destroyed in their response to the recalling firm. For questions and clarifications regarding this notification please call ProterixBio at 978-901-6649 or email [email protected]. Business hours are 8 am to 4:30 pm, Eastern Time.

    Distribution

    Domestic distribution to CA CO FL IA MA MO NH NY OH OK TX VA

    Quantity

    640 kits