FDA Recall
Terminated
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
Recall: Z-0156-2020
·
Initiated January 10, 2012
Recall
- Recall Number
- Z-0156-2020
- Event Number
- 83582
- Firm
- Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands
- FEI Number
- 2708
- Product Code
- JJF
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- January 10, 2012
- Terminated
- April 19, 2024
Description
V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
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
39 instruments