BEUDAMED
    FDA Recall Terminated

    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

    Recall: Z-0537-2014 · Initiated May 2, 2013

    Recall

    Recall Number
    Z-0537-2014
    Event Number
    65476
    Firm
    Remel Inc
    FEI Number
    1924669
    Product Code
    JTO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 2, 2013
    Posted
    December 18, 2013
    Terminated
    March 12, 2014
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    Description

    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

    Reason

    The product may give weak or false negative test results.

    Action

    ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). For questions regarding this recall call 913-888-0939.

    Distribution

    Nationwide Distribution

    Quantity

    768 kits