Drug recall
Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401…
FDA recall event 83582 · Class II · Vital Scientific N.V.
Key facts
| Event ID | 83582 |
|---|---|
| Recall numbers | Z-0154-2020, Z-0155-2020, Z-0156-2020, Z-0157-2020, Z-0158-2020 |
| Recalling firm | Vital Scientific N.V. |
| Product type | Devices |
| Products | 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., Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories., Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use, Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use, V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jan 10, 2012 |
| Report date | Oct 23, 2019 |
| Termination date | Apr 19, 2024 |
| City | Dieren |
| Country | Netherlands |
| FEI number | 2708 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: