BEUDAMED
    FDA Recall Terminated

    Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

    Recall: Z-0648-03 · Initiated October 16, 2002

    Recall

    Recall Number
    Z-0648-03
    Event Number
    25028
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 16, 2002
    Posted
    March 13, 2003
    Terminated
    August 21, 2003
    Address
    5440 Patrick Henry Drive, Santa Clara, CA, 95054

    Description

    Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT Model/List Number 01H73-01

    Reason

    Product elicits fluorescent signal interference due to contamination.

    Action

    On 10/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

    Distribution

    Nationwide and Argentina, Canada and Puerto Rico.

    Quantity

    1383 units