BEUDAMED
    FDA Enforcement Class II 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 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1636-2020
    Event ID
    85122
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 8, 2020
    Initiation Date
    February 21, 2020
    Classification Date
    April 1, 2020
    Termination Date
    October 5, 2020
    Address
    19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States

    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.

    Code Info

    FMRT-1-25-US: Lots 563010976, 563011620, 563011164, 5660397, 5660552 FMRT-1-10-US: Lot 563011618 FMRT-1-25-CA: Lot 563011195

    Distribution

    Nationwide domestic distribution. Foreign distribution to Canada.

    Quantity

    1654 kit boxes