BEUDAMED
    FDA Enforcement Class II Ongoing

    Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

    Recall: Z-2276-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2276-2021
    Event ID
    88324
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Laboratories, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    August 18, 2021
    Initiation Date
    July 12, 2021
    Classification Date
    August 12, 2021
    Address
    1921 Hurd Dr, N/A, Irving, TX, 75038-4313, United States

    Description

    Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

    Reason

    A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

    Code Info

    Model Number: LN 06P16-01 Serial numbers AS1001 through AS1330

    Distribution

    Worldwide distribution. US nationwide, Australia, Bahrain, Belgium, Brazil, China, Colombia, Croatia, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Mexico, Netherlands, Pakistan, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Tanzania, United Arab Emirates, United Kingdom, Ukraine and Zimbabwe.

    Quantity

    260 systems