BEUDAMED
    FDA Enforcement Class II Terminated

    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

    Recall: Z-2351-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2351-2015
    Event ID
    71614
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    June 30, 2015
    Classification Date
    August 7, 2015
    Termination Date
    February 13, 2017
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

    Reason

    A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

    Code Info

    lot 1463129, exp. date 31 May 2016

    Distribution

    Nationwide Distribution, including Puerto Rico and the country of Canada.

    Quantity

    4420 bottles