FDA Recall
Terminated
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Recall: Z-0158-2020
·
Initiated January 10, 2012
Recall
- Recall Number
- Z-0158-2020
- Event Number
- 83582
- Firm
- Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands
- FEI Number
- 2708
- Product Code
- JGS
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- January 10, 2012
- Terminated
- April 19, 2024
Description
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Reason
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Action
The firm reached out to consignees via phone to inform them of the affected product.
Distribution
US Nationwide in the states of NY, and UT
Quantity
6 instruments