BEUDAMED
    FDA Enforcement Class I Terminated

    AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.

    Recall: Z-2577-2018 · Reported August 15, 2018

    Enforcement

    Recall Number
    Z-2577-2018
    Event ID
    80404
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qiagen Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2018
    Initiation Date
    May 18, 2018
    Classification Date
    August 8, 2018
    Termination Date
    September 2, 2020
    Address
    19300 Germantown Rd, N/A, Germantown, MD, 20874-1415, United States

    Description

    AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.

    Reason

    Potential for control line not appearing on the test strip

    Code Info

    1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020

    Distribution

    Worldwide - US Nationwide distribution an in the country of , Canada

    Quantity

    1620 kits