Device product
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Z-0157-2020
Product summary
- Event
- Event 83582
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 instruments
- Official record key
device-enforcement:Z-0157-2020
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: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.
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.