BEUDAMED
    FDA Recall Terminated

    Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C

    Recall: Z-1833-2017 · Initiated March 10, 2017

    Recall

    Recall Number
    Z-1833-2017
    Event Number
    76838
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JMG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2017
    Posted
    April 17, 2017
    Terminated
    June 27, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C

    Reason

    Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

    Action

    Beckman Coulter sent an Urgent Medical Device Recall letter dated March 10, 2017, to inform them that Beckman Coulter has determined through customer feedback that a portion of the Access Ferritin Calibrators kit lot listed above contains a calibration card with an incorrect S5 calibrator concentration. The S5 concentration value printed on the card and encoded in the barcode is 1.500 (ng/mL) rather than the correct concentration of 1500 (ng/mL). Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Technical Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 the US and Canada and customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.

    Quantity

    889 kits total (6 kits in US)