BEUDAMED
    FDA Recall Terminated

    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

    Recall: Z-0193-2019 · Initiated June 29, 2018

    Recall

    Recall Number
    Z-0193-2019
    Event Number
    80774
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 29, 2018
    Terminated
    August 12, 2021
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.

    Reason

    Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and Ancillary Packs when more than one (1) lot of specific Reagent kits are loaded on the analyzer at the same time. 2. Sample barcodes may be incorrectly read 3. The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not run CEA dilutions at 50x and 100x. The Analyzer may post a Sample Integrity Error when 50x or 100x dilutions are ordered for Carcinoembryonic Antigen (CEA). Dilution factors lower than 50x and neat samples are not affected by this behavior. 4. The Atellica CH 930 Analyzer may continue to display the default reporting units after the reporting units have been changed. 5. The Atellica CH 930 Analyzer may not display results for sample if certain assays are configured to auto-dilute results above or below the assay measuring interval.

    Action

    Siemens issued an Urgent medical Device Correction, (UMDC ASW18-02.A.US) and Urgent Field Safety Notification (UFSN ASW18-02.A.OUS) on 6/29/18, via FedEx to the US Customer and via email distribution to countries Outside US (OUS). The field action letters explain the behaviors and informed Customers of action to be taken to prevent the behaviors from occurring. Siemens has released an updated software (SW) version (V), 1.14, which corrects the reported behaviors.

    Distribution

    Nationwide Foreign: Australia Austria Belgium Brazil Canada Croatia Czech Republic Denmark France Germany Greece Italy Japan Malaysia Mexico Netherlands Norway Poland Republic Korea Singapore Spain Sweden Switzerland U.A.E. United Kingdom

    Quantity

    92