BEUDAMED
    FDA Recall Terminated

    Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835

    Recall: Z-0525-2008 · Initiated May 21, 2007

    Recall

    Recall Number
    Z-0525-2008
    Event Number
    45918
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 21, 2007
    Posted
    February 6, 2008
    Terminated
    October 15, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835

    Reason

    Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the Evidence of Deterioration section of the Package Insert.

    Action

    A Product Corrective Action (PCA) letter was mailed on May 21, 2007, to all accounts that have ordered Flow-Count Fluorospheres, Part Number 7547053, Lot # 754801F. The letter advised that Beckman Coulter has confirmed absolute count recovery failures with assayed control cell products. Additionally, internal testing has indicated secondary fluorescent populations slightly above their indicated 20% of the total population as stated in the Evidence of Deterioration section of the Package Insert. The letter requests that users immediately discard any bottles of the product and call for a replacement. If no evidence of deterioration has been observed, the firm states that there should not be any negative impact to the results obtained. A response form is included and should be returned to the firm within 10 days. Questions regarding this recall can be addressed by contacting Beckman Coulter Customer Service at 1-800-526-7694.

    Distribution

    Worldwide Distribution --- including USA and country of Canada. ***CENTER COMMENTS -- The Center requests that the subject recall not be terminated until CDRH has determined that the firm has identified the root cause and performed an adequate CAPA to address the cause of the problem, i.e., quality control.***

    Quantity

    97 units in the US; 37 units Internationally