BEUDAMED
    FDA Recall Terminated

    Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.

    Recall: Z-2761-2011 · Initiated July 20, 2009

    Recall

    Recall Number
    Z-2761-2011
    Event Number
    55227
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CGR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 20, 2009
    Posted
    July 8, 2011
    Terminated
    April 27, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This assay is intended for in vitro diagnostic use.

    Reason

    The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. Beckman Coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica

    Action

    Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970. Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below. Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification. Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    1369 Kits