BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1684-2017
    Event ID
    76501
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Streck
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 5, 2017
    Initiation Date
    February 23, 2017
    Classification Date
    March 27, 2017
    Address
    7002 S 109th St, La Vista, NE, 68128-5729, United States

    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.

    Code Info

    UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018

    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