BEUDAMED
    FDA Recall Terminated

    Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.

    Recall: Z-2274-2016 · Initiated February 5, 2016

    Recall

    Recall Number
    Z-2274-2016
    Event Number
    74567
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JQC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 5, 2016
    Terminated
    January 17, 2017
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA. Product Usage: For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.

    Reason

    A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.

    Action

    Beckman Coulter sent an Important Product Notice Recall letter dated February 5, 2016 to customer. The letter identified the affected product problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form. Customers with questions are instructed to contact our Customer Support Center " Via website, http://www.beckmancoulter.com/customersupport/support " Via phone, call 800-369-0333 the United States and Canada " Outside the United States and Canada, contact your local Beckman Coulter Representative.

    Distribution

    Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain

    Quantity

    62 units total (33 units in US)