BEUDAMED
    FDA Recall Open, Classified

    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

    Recall: Z-0749-2022 · Initiated February 3, 2022

    Recall

    Recall Number
    Z-0749-2022
    Event Number
    89604
    Firm
    Abbott Laboratories, Inc
    FEI Number
    1628664
    Product Code
    MZA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 3, 2022
    Address
    1921 Hurd Dr, Irving, TX, 75038-4313

    Description

    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

    Reason

    Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

    Action

    On February 3, 2022, Abbott issued two "Urgent Product Correction" notifications. For US customers these notification where delivered by Abbott personnel. For OUS consignees letters were provided by Abbott personnel or by email. During the week of February 25, 2022, an updated letter was provided to US customers containing additional information. In addition to informing consignees about the recall the firm provided the following instructions Please perform the necessary immediate actions, if utilizing the Alinity s HIV Ag/Ab Combo and Alinity s Anti-HCV II assays while operating on Alinity s System SW version 2.8.0, to continue to use the Alinity s System. These actions mitigate potential impact for false reactive results when using the Alinity s HIV Ag/Ab Combo Reagent kit. The Alinity s HIV Ag/Ab Combo and Alinity s Anti-HCV II assays are not installed or do not run on the same Alinity s System. - No action is required. The Alinity s Anti-HCV II assay is not calibrated and run on the same processing lane as the Alinity s HIV Ag/Ab Combo assay. - Maintain the current assay configuration and ensure the Alinity s HIV Ag/Ab Combo assay is not run on the same processing lane as the Alinity s Anti-HCV II assay. The Alinity s Anti-HCV II assay and the Alinity s HIV Ag/Ab Combo assay are calibrated and run on the same processing lane. - Contact your local area customer service representative to assess the configuration and uninstall/reinstall the assays to run on separate processing lanes or instruments. Please review this letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported Alinity s HIV Ag/Ab Combo assay test results while operating on Alinity s System SW version 2.8.0. If you have forwarded the product listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. Please complete and return the Customer Re

    Distribution

    Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Jordan Kuwait and Mexico.

    Quantity

    306 units