BEUDAMED
    FDA Recall Open, Classified

    Atellica IM 1600 Analyzer, SMN 11066000

    Recall: Z-0125-2022 · Initiated September 28, 2021

    Recall

    Recall Number
    Z-0125-2022
    Event Number
    88792
    Firm
    Siemens Healthcare Diagnostics, Inc
    FEI Number
    1219913
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 28, 2021
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Atellica IM 1600 Analyzer, SMN 11066000

    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.

    Action

    On September 27, 2021, the firm initiated notifications to affected customers. Customer distribution included all customers located in a city at an altitude of 350 meters (1148 feet) or higher. Customers were informed that 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 350 (m) or 1148 (ft) above sea level. The letters provide directions for mitigating the potential for leakage. If you have any questions, contact your local Siemens Healthineers technical support representative.

    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

    1733