BEUDAMED
    FDA Recall Terminated

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    Recall: Z-0008-2022 · Initiated September 2, 2021

    Recall

    Recall Number
    Z-0008-2022
    Event Number
    88626
    Firm
    Abbott Molecular, Inc.
    FEI Number
    3005248192
    Product Code
    QJR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 2, 2021
    Posted
    October 14, 2021
    Terminated
    July 23, 2024
    Address
    1300 E Touhy Ave, Des Plaines, IL, 60018-3315

    Description

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    Reason

    There is a potential for false positive results.

    Action

    The firm issued an Urgent Field Safety Notice/Field Correction Recall 09/02/2021 to all impacted customers. Per the customer letter, all positives are to be considered presumptive until the Alinity m SARS-CoV-2 Application Specification file version 5 or the updated Alinity m Resp-4-Plex Application Specification file is implemented at the customer site. On 03/30/2022, Abbott Molecular issued a follow-up Urgent Field Safety Notice/Field Correction Recall letter to all customers who ordered Alinity m SARS-CoV-2 AMP Kit Emergency Use Authorization (EUA), List Number 09N78-095 and/or Alinity m Resp-4-Plex AMP Kit EUA, List Number 09N79-096 used with the Alinity m System. Also to customers who ordered Alinity m SARS-CoV-2 AMP Kit (CE), List Number 09N78-090 or 09N78-091 and/or Alinity m Resp-4-Plex AMP Kit (CE), List Number 09N79-090 used with the Alinity m System. The Customer Letter explains Abbott has updated the existing Application Specification files for Alinity m SARS-CoV-2 and Resp-4-Plex to further reduce the potential for carryover. FDA has not yet authorized the Alinity m SARS-CoV-2 Application Specification file version 6 update or the Alinity m Resp-4-Plex Application Specification file version 5 update. Implementation of the modification for Alinity m SARS-CoV-2 and Resp-4-Plex will occur when the update to the Application Specification file has been authorized. A Molecular Diagnostics Abbott Representative will be contacting you once the updated Application Specification files are available. If you have any questions, please contact your local Molecular Diagnostics Abbott representative or call Abbott Technical Support at 1-800-553-7042 Option 2.

    Distribution

    Worldwide Distribution. US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CZECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, HONG KONG, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UNITED KINGDOM, and VIETNAM.

    Quantity

    5855 units