BEUDAMED
    FDA Recall Terminated

    AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)

    Recall: Z-1636-2020 · Initiated February 21, 2020

    Recall

    Recall Number
    Z-1636-2020
    Event Number
    85122
    Firm
    Qiagen Sciences LLC
    FEI Number
    3003572099
    Product Code
    NQM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 21, 2020
    Terminated
    October 5, 2020
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    Description

    AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)

    Reason

    An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.

    Action

    On February 21, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed of the incorrect rinse time on the product's labeling, and reminded of the correct rinse time of 1 (one) minute. Customers were asked to immediately share the contents of the customer letter with all users of the AmniSure ROM Test in their facility to ensure awareness. Test users should refer to the instructions for use (IFU) included in each kit box. The firm is not asking for product to be returned. Customers were asked to complete and return an attached response form.

    Distribution

    Nationwide domestic distribution. Foreign distribution to Canada.

    Quantity

    1654 kit boxes