BEUDAMED
    FDA Recall 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 · Initiated July 18, 2017

    Recall

    Recall Number
    Z-0394-2018
    Event Number
    78808
    Firm
    Becton Dickinson & Co.
    FEI Number
    1119779
    Product Code
    NSU
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    July 18, 2017
    Terminated
    July 9, 2018
    Address
    7 Loveton Cir, Sparks, MD, 21152-9212

    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.

    Action

    Customers were notified via UPS on 07/18/2017. The recall for BD MAX" Vaginal Panel and BD MAX" UVE Specimen Collection Kit was initiated on July 18, 2017 and expanded to include BD MAX" CT/GC/TV on August 11, 2017. The recall expansion letter to customers was dated 08/14/2017.

    Distribution

    US and OUS.