BEUDAMED
    FDA Enforcement Class II Ongoing

    Alinity m System, Part No. 08N53-002

    Recall: Z-0462-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0462-2022
    Event ID
    89168
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Molecular, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 12, 2022
    Initiation Date
    December 6, 2021
    Classification Date
    January 6, 2022
    Address
    1300 E Touhy Ave, N/A, Des Plaines, IL, 60018-3315, United States

    Description

    Alinity m System, Part No. 08N53-002

    Reason

    There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high.

    Code Info

    Alinity m System, Model 08N53-002, all serial numbers

    Distribution

    Worldwide distribution - US distribution and the countries of Australia, Austria, Belgium, Brazil, Cambodia, Canada, Chile, Colombia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Malawi, Malaysia, Mexico, Montenegro, Morocco, Mozambique, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Uganda, United Kingdom, and Vietnam

    Quantity

    742 devices