ELITech Group B.V.: Medical Device Recall in 2019 - (Recall #: Z-2764-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: July 12, 2016

Date Posted: October 9, 2019

Recall Number: Z-2764-2019

Event ID: 83381

Reason for Recall:

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

Status: Terminated

Product Quantity: 89 units

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

Distribution Pattern:

US Nationwide distribution including the state of NY.

Voluntary or Mandated:

Voluntary: Firm initiated