BEUDAMED
    FDA Recall Open, Classified

    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

    Recall: Z-1253-2022 · Initiated April 13, 2022

    Recall

    Recall Number
    Z-1253-2022
    Event Number
    90153
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JLW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 13, 2022
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens Siemens Material Number (SMN): 11066000

    Reason

    Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

    Action

    Siemens issued an Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 04/13/2022 and an Urgent Field Safety Notice (UFSN) was issued to all OUS. Letter states reason for recall, health risk and action to take: If your facility has multiple lots of T3 available for use and some kit lots are below lots ending in 244, follow the steps below to ensure that T3 results will be correct for all available lots until all kit lots available for use are kit lots ending in 244 or above. Ensure that all IM modules connected to an Atellica Solution have only 1 lot of T3 reagent (all IM modules have the same lot of T3 reagent packs) loaded onto every IM. For reagent kit lots below lots ending in 244: Rescan the Master Curve Card (MCC) for the T3 reagent lot that is on the Atellica IM before processing with that reagent lot, following instructions in the Atellica Online Help (SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D Barcodes ). Note: If the IM is rebooted while using kit lots below lots ending in 244, the MCC will need to be re-scanned before samples are processed. For reagent lots ending in 244 and above: Rescan the Master Curve Card (MCC) for the T3 reagent kit lot that is on the Atellica IM, following instructions in the Atellica Online Help (SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D Barcodes . Reboot all IM modules connected to Atellica Solution following instructions in the Atellica Online Help (SMN 11313586, section titled Shutting Down and Powering Off Analyzers within the System ) when changing from reagent kit lots below lots ending in 244 to a reagent pack associated with kit lots ending in 244 or above before processing with that reagent kit lot. Please review this letter with your Medical Director. Complete and return the Field Action Effectiveness Check Form attached to this letter within 30 days.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam.

    Quantity

    2,321