BEUDAMED
    FDA Recall Terminated

    AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138

    Recall: Z-0120-2008 · Initiated October 3, 2007

    Recall

    Recall Number
    Z-0120-2008
    Event Number
    44937
    Firm
    AmniSure International LLC
    FEI Number
    3005345832
    Product Code
    JJX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 3, 2007
    Posted
    January 19, 2008
    Terminated
    February 6, 2008
    Address
    31 Sacramento St, # 5, Cambridge, MA, 02138-1820

    Description

    AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138

    Reason

    Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect"

    Action

    AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.

    Distribution

    Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador

    Quantity

    319,976 units