BEUDAMED
    FDA Recall Terminated

    Access Immunoasay Systems Digoxin Reagent

    Recall: Z-0576-05 · Initiated February 23, 2005

    Recall

    Recall Number
    Z-0576-05
    Event Number
    31253
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    KXT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2005
    Posted
    March 8, 2005
    Terminated
    September 2, 2005
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Immunoasay Systems Digoxin Reagent

    Reason

    Variability in results on Patient and QC results of 20-25%, high and low.

    Action

    Letters were sent to customers via UPS overnite, they request that alternative methods be used for patient testing until new material is made available. Customers are requested to ask for replacements using a fax back form.

    Distribution

    Nationwide and Canada

    Quantity

    4352 domestically.