BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Kiestra" ReadA; Catalog No.: 446948.

    Recall: Z-1658-2026 · Reported April 8, 2026

    Enforcement

    Recall Number
    Z-1658-2026
    Event ID
    98473
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    BD KIESTRA LAB AUTOMATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2026
    Initiation Date
    February 6, 2026
    Classification Date
    March 27, 2026
    Address
    Marconilaan 6, Drachten, N/A, Netherlands

    Description

    BD Kiestra" ReadA; Catalog No.: 446948.

    Reason

    In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.

    Code Info

    Catalog No.: 446948; UDI-DI: 00382904469481; Serial Numbers: All;

    Distribution

    Domestic: KS, MD, MN, NJ, TX, VA; International: Australia, Austria, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Kuwait, Mexico, Morocco, Netherlands, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, United Kingdom;

    Quantity

    82 units (7 US, 65 OUS)