BEUDAMED
    FDA Enforcement Class II Terminated

    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

    Recall: Z-1580-2016 · Reported May 4, 2016

    Enforcement

    Recall Number
    Z-1580-2016
    Event ID
    73747
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hologic, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 4, 2016
    Initiation Date
    March 31, 2016
    Classification Date
    April 27, 2016
    Termination Date
    August 9, 2016
    Address
    10210 Genetic Center Dr, N/A, San Diego, CA, 92121-4362, United States

    Description

    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

    Reason

    Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing.

    Code Info

    Lot Numbers: C33xx C34xx C35xx (xx denotes sublots)

    Distribution

    Distributed in the states of OH, AL, IL, AZ, AR, NJ, TX, GA, CO, DE, NC, MI, FL, ME, CA, IN, OR, KS, KY, MO, WA, NY, OK, WV, CT, IA, LA, RI, MA, and PA, and in the country of Canada.

    Quantity

    2580 total