Recall Z-0158-2020
Vital Scientific N.V. · initiated January 10, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.
Codes / lots: serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.
Reason for recall
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
FDA-determined cause: Component design/selection
Action taken
The firm reached out to consignees via phone to inform them of the affected product.
Details
- Recall number
- Z-0158-2020
- Initiated
- January 10, 2012
- Terminated
- April 19, 2024
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Quantity
- 6 instruments
- Distribution
- US Nationwide in the states of NY, and UT
- Recalling firm
- Vital Scientific N.V., Dieren
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0154-2020 Class II | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry…The action was initiated due power supply failure. During a power supply failure the instruments… | 01/10/2012Terminated |
| Z-0155-2020 Class II | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry…The action was initiated due power supply failure. During a power supply failure the instruments… | 01/10/2012Terminated |
| Z-0156-2020 Class II | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry…The action was initiated due power supply failure. During a power supply failure the instruments… | 01/10/2012Terminated |
| Z-0157-2020 Class II | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog #…The action was initiated due power supply failure. During a power supply failure the instruments… | 01/10/2012Terminated |