Z-2764-2019 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 9, 2019
- Initiation Date
- July 12, 2016
- Termination Date
- February 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89 units
Product 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 for Recall
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Distribution Pattern
US Nationwide distribution including the state of NY.
Code Information
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