BEUDAMED
    FDA Recall Open, Classified

    DYNEX Agility, Agility Analyzer, Model No. 67000

    Recall: Z-1222-2022 · Initiated July 5, 2020

    Recall

    Recall Number
    Z-1222-2022
    Event Number
    90099
    Firm
    Dynex Technologies, Inc.
    FEI Number
    1117676
    Product Code
    LXG
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    July 5, 2020
    Address
    14340 Sullyfield Cir, Chantilly, VA, 20151-1621

    Description

    DYNEX Agility, Agility Analyzer, Model No. 67000

    Reason

    Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the correct control, which may lead to delayed patient results.

    Action

    The firm first notified customers via mail and email between June and July 2020. Although only 17 units had been released with v1.4.3 installed, the firm notified all customers in possession of a device out of an abundance of caution. Customers were given workaround instructions to prevent the problem from occurring while the software was being corrected. Customers then received a follow up Field Safety Notice dated September 29, 2020. Distributors were asked to pass on the notification to any downstream customer accounts. The Agility software was updated to v1.4.7 to prevent controls and calibrators from sharing the same name. The update should prevent recurrence of the issue.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, CA, DC, FL, GA, IL, IN, MA, MD, MI, NE, NJ, NY, OH, PA, PR, TN, TX, UT, VA, WI, WV and the countries of Belgium, Brazil, China, Czech Republic, France, Germany, Mexico, Qatar, Romania, Russia, South Korea, Switzerland, Taiwan, and UK.

    Quantity

    218 units (17 installed with v1.4.3)