Recall Z-2764-2019 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
ELITech Group B.V.
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 spectropho
| Date | Jul 12, 2016 |
| Status | Terminated |
| Reason | Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. |
| Root cause | Software design |
| Action | Consignees were notified via a non-mandatory upgrade in July 2016 |
| Quantity | 89 units |
| Distribution | US Nationwide distribution including the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102647 | ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE... Elitechgroup Vital Scientific BV, Mar 24, 2011 |