BEUDAMED
    FDA Recall Terminated

    Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000

    Recall: Z-1127-2007 · Initiated June 19, 2007

    Recall

    Recall Number
    Z-1127-2007
    Event Number
    38234
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    GKP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 19, 2007
    Posted
    August 7, 2007
    Terminated
    May 23, 2012
    Address
    113 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000

    Reason

    ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

    Action

    Instrumentation Laboratory notiifed the distributor Beckman Coulter on 6/19/2007. Beckman Coulter notified their customers and provided a copy with the Instructions for Recovery Procedure on how to avoid contamination from probe leaks.

    Distribution

    Nationwide.

    Quantity

    94