BEUDAMED
    FDA Enforcement Class II Terminated

    BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.

    Recall: Z-0394-2018 · Reported January 31, 2018

    Enforcement

    Recall Number
    Z-0394-2018
    Event ID
    78808
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 31, 2018
    Initiation Date
    July 18, 2017
    Classification Date
    January 19, 2018
    Termination Date
    July 9, 2018
    Address
    7 Loveton Cir, N/A, Sparks, MD, 21152-9212, United States

    Description

    BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.

    Reason

    BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.

    Code Info

    UDI: 30382904433766. All Lot numbers: All. All *.Catalog number 442970 was originally distributed in Europe only. Catalog number 443824 was discontinued and replaced with 442970 for US sales. Catalog number 442970 is now distributed worldwide. Not Distributed in US.

    Distribution

    US and OUS.

    Quantity

    N/A