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.
Recall
- Recall Number
- Z-2764-2019
- Event Number
- 83381
- Firm
- ELITech Group B.V. Van Rensselaerweg 4 Spankeren Netherlands
- FEI Number
- 3001576181
- Product Code
- JJE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- July 12, 2016
- Terminated
- February 4, 2022
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.
Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.
Consignees were notified via a non-mandatory upgrade in July 2016
US Nationwide distribution including the state of NY.
89 units