BEUDAMED
    FDA Recall Terminated

    Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318.

    Recall: Z-1160-2008 · Initiated September 19, 2007

    Recall

    Recall Number
    Z-1160-2008
    Event Number
    45955
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CFP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 19, 2007
    Posted
    June 25, 2008
    Terminated
    May 9, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems. Beckman Coulter, Inc., Chaska, MN 55318.

    Reason

    False negative results when used to test serum samples (as compared to plasma samples).

    Action

    On September 19, 2007, Beckman Coulter mailed to its consignees an Urgent Product Corrective Action Letter informing them that the affected lots of the product were giving false negative results when used to test serum samples (as compared to plasma samples). The letter instructed consignees to discontinue using the affected lots of the product, and to re-test using an EDTA plasma sample if there was any discordance between the results of the serum sample (if it was obtained using an affected lot of the product) as compared with the clinical presentaion of the patient and the results of other diagnostic tests. The letter also instructed consignees to return, within 10 days, the Response Sheet .

    Distribution

    Worldwide: including USA and Canada.

    Quantity

    8,205 units in the US; 332 in Canada