BEUDAMED
    FDA Enforcement Class III Terminated

    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

    Recall: Z-2764-2019 · Reported October 9, 2019

    Enforcement

    Recall Number
    Z-2764-2019
    Event ID
    83381
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    ELITech Group B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2019
    Initiation Date
    July 12, 2016
    Classification Date
    September 30, 2019
    Termination Date
    February 4, 2022
    Address
    Van Rensselaerweg 4, N/A, Spankeren, N/A, N/A, Netherlands

    Description

    Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

    Reason

    Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

    Code Info

    1. 14-1301 2. 14-1304 3. 14-1308 4. 14-1314 5. 14-1315 6. 14-1323 7. 14-1324 8. 14-1336 9. 15-1328 10. 15-1332 11. 15-1333 12. 15-1334 13. 15-1335 14. 15-1336 15. 15-1337 16. 15-1338 17. 15-1339 18. 16-1301 19. 16-1302 20. 16-1304 21. 16-1305 22. 16-1312 23. 17-1335

    Distribution

    US Nationwide distribution including the state of NY.

    Quantity

    89 units