BEUDAMED
    FDA Recall Terminated

    STA-R blood coagulation analyzer. Catalog Number 57160.

    Recall: Z-1422-05 · Initiated June 20, 2005

    Recall

    Recall Number
    Z-1422-05
    Event Number
    32714
    Firm
    Diagnostica Stago, Inc.
    FEI Number
    2245451
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 20, 2005
    Posted
    August 30, 2005
    Terminated
    August 30, 2005
    Address
    5 Century Dr, Parsippany, NJ, 07054-4607

    Description

    STA-R blood coagulation analyzer. Catalog Number 57160.

    Reason

    Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.

    Action

    Alert on the problem was sent out on 6/20/2005 to all customers alerting the problem and instructions on how to prevent the problem. The units are not be to returned.

    Distribution

    Units were distributed to clinics and hospitals nationwide.

    Quantity

    215 units