BEUDAMED
    FDA Recall Terminated

    Synchron Systems Acetaminophen Reagent, part No. 472169.

    Recall: Z-1026-04 · Initiated September 4, 2003

    Recall

    Recall Number
    Z-1026-04
    Event Number
    28908
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    LDP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 4, 2003
    Posted
    July 20, 2004
    Terminated
    January 4, 2005
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Synchron Systems Acetaminophen Reagent, part No. 472169.

    Reason

    Firm shortened calibration frequency to 7 days from 14 days.

    Action

    Firm issued letters to customers indicating need to shorten the calibration period from 14 to 7 days.

    Distribution

    Nationwide and Canada

    Quantity

    unknown