BEUDAMED
    FDA Recall Terminated

    SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

    Recall: Z-0886-06 · Initiated March 30, 2006

    Recall

    Recall Number
    Z-0886-06
    Event Number
    35258
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    LEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2006
    Posted
    May 18, 2006
    Terminated
    February 29, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

    Reason

    Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.

    Action

    A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)

    Distribution

    Nationwide & Canada

    Quantity

    3147