BEUDAMED
    FDA Recall Terminated

    ACL Futura Instrument Analyzer

    Recall: Z-0736-04 · Initiated March 4, 2004

    Recall

    Recall Number
    Z-0736-04
    Event Number
    28485
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2004
    Posted
    July 20, 2004
    Terminated
    January 28, 2016
    Address
    113 Hartwell Ave, Lexington, MA, 02421-3125

    Description

    ACL Futura Instrument Analyzer

    Reason

    Software may cause instrument to omit step causing reagent carrover which may effect patient test result

    Action

    Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.

    Distribution

    Florida Canada

    Quantity

    1450 units