BEUDAMED
    FDA Recall 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 · Initiated June 30, 2015

    Recall

    Recall Number
    Z-2351-2015
    Event Number
    71614
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    GTY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 30, 2015
    Posted
    August 7, 2015
    Terminated
    February 13, 2017
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail.

    Distribution

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

    Quantity

    4420 bottles