BEUDAMED
    FDA Enforcement Class II Ongoing

    PE Centrifuge, REF: B36365, a component of the Power Express

    Recall: Z-2979-2024 · Reported September 11, 2024

    Enforcement

    Recall Number
    Z-2979-2024
    Event ID
    95064
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Beckman Coulter Biomedical GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 11, 2024
    Initiation Date
    July 17, 2024
    Classification Date
    September 5, 2024
    Address
    Sauerbruchstr. 50, Munchen, N/A, Germany

    Description

    PE Centrifuge, REF: B36365, a component of the Power Express

    Reason

    The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.

    Code Info

    UDI: (01)15099590673550/ All serial numbers Lots

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.