BEUDAMED
    FDA Recall Open, Classified

    Alinity m System, Part No. 08N53-002

    Recall: Z-0462-2022 · Initiated December 6, 2021

    Recall

    Recall Number
    Z-0462-2022
    Event Number
    89168
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    MZP
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 6, 2021
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    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.

    Action

    On December 06, 2021 Abbott Molecular issued a Product Recall letter to all customers who received an Alinity m instrument (List Number 08N53 002). Customers are instructed to follow the Necessary Actions outlined in the Customer Letter until an Abbott Molecular representative adjusts the amplification detection clamp height on the Alinity m System. Abbott personnel will follow up with customers by e mailing and or follow up visits/phone calls.

    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