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U.S. Department of Health and Human Services

Class 3 Device Recall VivaProE

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  Class 3 Device Recall VivaProE see related information
Date Initiated by Firm July 12, 2016
Create Date September 30, 2019
Recall Status1 Terminated 3 on February 04, 2022
Recall Number Z-2764-2019
Recall Event ID 83381
510(K)Number K102647  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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.
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 
Recalling Firm/
Manufacturer		 ELITech Group B.V.
Van Rensselaerweg 4
Spankeren Netherlands
Manufacturer Reason
for Recall		 Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ELITECHGROUP VITAL SCIENTIFIC BV
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