Device product
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Z-0158-2020
Product summary
- Event
- Event 83582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 instruments
- Official record key
device-enforcement:Z-0158-2020
Official wording
Reason: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Code information: serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.
Distribution pattern: US Nationwide in the states of NY, and UT
Derived failure modes
-
Unknown
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.