BEUDAMED
    FDA Enforcement Class II Terminated

    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    Recall: Z-0538-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0538-2014
    Event ID
    65476
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Remel Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 25, 2013
    Initiation Date
    May 2, 2013
    Classification Date
    December 18, 2013
    Termination Date
    March 12, 2014
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    Reason

    The product may give weak or false negative test results.

    Code Info

    Lot 1149576, exp January 2014

    Distribution

    Nationwide Distribution

    Quantity

    109 kits