BEUDAMED
    FDA Recall Terminated

    SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920

    Recall: Z-2653-2010 · Initiated June 28, 2010

    Recall

    Recall Number
    Z-2653-2010
    Event Number
    56247
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    DEW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 28, 2010
    Posted
    September 30, 2010
    Terminated
    July 31, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent, Part Number: 467920

    Reason

    The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reagent lots M812164 or M902345. Using these reagent lots, some samples deficient in IgA have yielded results in the normal range. Other samples with normal levels of IgA have yielded falsely high results.

    Action

    A Product Corrective Action (PCA) letter was sent on the week of June 28, 2010 to the affected customers. The letter provided the customers with an explanation of the problem identified and advised customers to discontinue use of the affected lots of the SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent. Customers were instructed to: (1) Discontinue use of Ig-A reagent lots M812164 and M902345. Contact your Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada or contact your local Beckman Coulter Representative to discuss reagent replacement options. (2) You may need to re-evaluate samples for IgA that were tested with either of the listed lots of Ig-A reagent. (3) Please complete and return the enclosed response form within 10 days so that we may maintain our records. Customers were also instructed to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If you have forwarded the affected products listed above to another laboratory, please provide a copy of this letter to them. If they have any questions regarding this Product Corrective Action letter, customers were told to contact our Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Requests, or call (800) 854-3633 in the United States and Canada.

    Distribution

    US Nationwide & Canada

    Quantity

    852 units