BEUDAMED
    FDA Recall Open, Classified

    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

    Recall: Z-1684-2017 · Initiated February 23, 2017

    Recall

    Recall Number
    Z-1684-2017
    Event Number
    76501
    Firm
    Streck
    FEI Number
    1950302
    Product Code
    GIM
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    February 23, 2017
    Posted
    March 8, 2017
    Address
    7002 S 109th St, La Vista, NE, 68128-5729

    Description

    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

    Reason

    Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

    Action

    On February 23, 2017, Streck electronically notified customers of the updated device correction. The recalling firm used an electronic mail alert to notify all of their customers the IFU for the recalled product had been revised. The specified the revision included phlebotomy guidelines specific to the 2.0 ml blood collections tubes. The revised IFU was provided as a link in the email. The recalling firm is reportedly able to monitor the access of the revised IFU to ensure each customer has received the information. For further questions, please call (402) 333-1982.

    Distribution

    Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.

    Quantity

    128,692 tubes