BEUDAMED
    FDA Recall Terminated

    Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.

    Recall: Z-1381-05 · Initiated April 27, 2005

    Recall

    Recall Number
    Z-1381-05
    Event Number
    31937
    Firm
    International Technidyne Corp.
    FEI Number
    1000526865
    Product Code
    JBP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 27, 2005
    Posted
    August 23, 2005
    Terminated
    August 25, 2005
    Address
    6 Olsen Ave, Edison, NJ, 08820-2419

    Description

    Hemochron Jr. Whole Blood Microcoagulation system Low Range Activated Clotting Time. ACT-LR Cuvettes. In vitro diagnostic use, non-sterile, Packaged in individual foil pouches. 45 foil pouches per shelf carton box. Mfg. by International Technidyne Corp, Edison, NJ 08820.

    Reason

    Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.

    Action

    Recall letter was sent out on 4/27/2005 via First Class Mail.

    Distribution

    Products were distributed domestically to customers nationwide. Products were also distributed internationally to customers in the following countries: Italy, Sweden, Norway, Germany, and Japan. Products were distributed to the VA Medical Center, Los Angeles, CA 90073.

    Quantity

    924 boxes x 45 cuvettes per box