BEUDAMED
    FDA Recall Open, Classified

    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

    Recall: Z-1021-2022 · Initiated March 3, 2022

    Recall

    Recall Number
    Z-1021-2022
    Event Number
    89953
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    1219913
    Product Code
    CHP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 3, 2022
    Address
    333 Coney St, East Walpole, MA, 02032-1516

    Description

    Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots

    Reason

    Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results

    Action

    Siemens issued an Urgent Medical Device Correction AIMC 22-03.A.US and Urgent Field Safety Notice AIMC 22-03.A.OUS on 3/3/22. Letter states reason, health risk and action to take: Customers must discontinue use of plasma specimens for testing with the Atellica IM and ADVIA Centaur eE2 assays until further notice. Customers may continue to use the Atellica IM eE2 and ADVIA Centaur eE2 assays with serum specimens. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Questions: contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative

    Distribution

    Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.

    Quantity

    374 units