BEUDAMED
    FDA Recall 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 · Initiated May 18, 2018

    Recall

    Recall Number
    Z-2577-2018
    Event Number
    80404
    Firm
    Qiagen Sciences, Inc.
    FEI Number
    3003572099
    Product Code
    NQM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    May 18, 2018
    Posted
    July 13, 2018
    Terminated
    September 2, 2020
    Address
    19300 Germantown Rd, Germantown, MD, 20874-1415

    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

    Action

    On May 18, 2018 QIAGEN issued Urgent Voluntary Medical Device Recall notices and response forms to customers. Customers were advised to take the following actions: 1) Immediately discontinue use of all impacted lots and return all unused product to QIAGEN. 2) Share the Voluntary Medical Device Recall Notice with all users of the AmniSure ROM Test in your facility to ensure they are aware of this recall. 3) Use the Return Response form to confirm receipt of the notification and to record quantity of material to return. If you have any questions regarding this notice, please contact Technical Services at 1-800-344-3631.

    Distribution

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

    Quantity

    1620 kits