BEUDAMED
    FDA Recall Terminated

    COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use

    Recall: Z-0805-03 · Initiated March 28, 2003

    Recall

    Recall Number
    Z-0805-03
    Event Number
    26040
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    JQW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2003
    Posted
    May 9, 2003
    Terminated
    October 14, 2003
    Address
    200 South Kraemer Blvd W, 337, Brea, CA, 92822

    Description

    COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use

    Reason

    Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

    Action

    The firm sent notification letter and modified operating instructions by mail on March 28, 2003.

    Distribution

    USA and Canada

    Quantity

    91