BEUDAMED
    FDA Enforcement Class II Ongoing

    Atellica IM 1300 Analyzer, SMN 11066001

    Recall: Z-0124-2022 · Reported October 27, 2021

    Enforcement

    Recall Number
    Z-0124-2022
    Event ID
    88792
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 27, 2021
    Initiation Date
    September 28, 2021
    Classification Date
    October 16, 2021
    Address
    333 Coney St, N/A, East Walpole, MA, 02032-1516, United States

    Description

    Atellica IM 1300 Analyzer, SMN 11066001

    Reason

    Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result, customers at these altitudes may observe an increased number of Reagent Volume Check Errors.

    Code Info

    All units

    Distribution

    Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX UT VA WA WI WY. Foreign distribution worldwide.

    Quantity

    1193