BEUDAMED
    FDA Enforcement Class II 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 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2274-2016
    Event ID
    74567
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    February 5, 2016
    Classification Date
    July 22, 2016
    Termination Date
    January 17, 2017
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    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.

    Code Info

    AFB13H005, AFB13H008, AFB13H012, AFB13K002, AFB13K005, AFB13K008, AFB13J002, AFB13J003, AFB13J004, AFB13J005, AFB13J007, AFB15J001, AFB15C010, AFB13K009, AFB14H001, AFB15C008, AFB15C003, AFB15C005, AFB15C004, AFB15C006, AFB14H005, AFB14H003, AFB13K004, AFB13K006, AFB13K007, AFB13J008, AFB13K001, AFB13J006, AFB13J010, AFB13H013, AFB13H009, AFB13H003, AFB13H004

    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)