Reported Oct 9, 2019 · Terminated
Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is…
ELITech Group B.V.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ELITech Group B.V. · Van Rensselaerweg 4 · Spankeren, N/A · N/A
Is this the product you have?
- Viva-ProE Systems, Model # 6003-670
- UDI03661540600357 -
- Product UsageThe 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 modulesone 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
- Lot codes and dates
23 of 23 products
Products covered by this recall # Product as published 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 - Amount recalled
- 89 units
Where it was sold
- Nationwide
- NY
Why it was recalled
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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