BEUDAMED
    FDA Recall Terminated

    Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394

    Recall: Z-0060-04 · Initiated September 22, 2003

    Recall

    Recall Number
    Z-0060-04
    Event Number
    27334
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CHL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 22, 2003
    Posted
    October 24, 2003
    Terminated
    February 4, 2004
    Address
    200 Prospect Street, Waltham, MA, 02454

    Description

    Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394

    Reason

    Degradation of the magnesium sensor could result in low ionozed magnesium patient samples

    Action

    Nova Biomedical contacted customers by telephone beginning on 9/26/03. Each account was faxed or mailed Customer Information Bulletin requesting the discard of Mg++ sensors in inventory that are greater than 4 months old from date of manufacture. Replacement product will be issued.

    Distribution

    Natinwide Foreign: Italy, Czech, Japan, Taiwan, Hungary, India, Israel, Mexico, Canada, Germany,Switzerland, Tunisia, Korea, Brazil, Greece, Coatia, China, France, Turkey, Thailand, Argentina. Government: VA Decator, GA

    Quantity

    659 units