Z-2764-2019Class III

Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 -

Name: Z-2764-2019 Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 -
Creator: ELITech Group B.V.
Published: 2016-07-12
License: https://open.fda.gov/license/

VitalScientific / initiated 2016-07-12 / Terminated / root cause: software

FDA source

ELITech Group B.V. began a recall of Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system... on 2016-07-12. FDA classified it as Class III and gives the reason as "Software malfunction; The action being taken due to the device becoming inoperable due to software lockup". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2764-2019
Classification: Class III
Status: Terminated
Initiated: 2016-07-12
Posted: 2019-09-30
Terminated: 2022-02-04
Recalling firm: VitalScientific
Product: 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 code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified via a non-mandatory upgrade in July 2016
Quantity in commerce: 89 units
Distribution: US Nationwide distribution including the state of NY.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2764-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2764-2019	Class III	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-30

Product code JJE

K102647Class IIElitech Clinical Systems Selectra Prom/elical 2/Elitrol I and Elitrol Ii/ast/got 4+1 Sl/potassium, Sodium, Chloride...Elitechgroup Vital Scientific BV / cleared 2011-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)