BEUDAMED
    FDA Recall Terminated

    ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent

    Recall: Z-0915-05 · Initiated May 19, 2005

    Recall

    Recall Number
    Z-0915-05
    Event Number
    32155
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 19, 2005
    Posted
    June 21, 2005
    Terminated
    December 6, 2006
    Address
    113 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent

    Reason

    Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy

    Action

    Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005.

    Distribution

    Nationwide Canada

    Quantity

    617 units