Recall Z-0155-2020
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
Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
Codes / lots: serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325.
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-0155-2020
- Initiated
- January 10, 2012
- Terminated
- April 19, 2024
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Quantity
- 75 units
- 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-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 |
| Z-0158-2020 Class II | Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical…The action was initiated due power supply failure. During a power supply failure the instruments… | 01/10/2012Terminated |