Drug recall
V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an…
FDA recall event 83648 · Class II · Vital Scientific N.V.
Key facts
| Event ID | 83648 |
|---|---|
| Recall numbers | Z-0038-2020 |
| Recalling firm | Vital Scientific N.V. |
| Product type | Devices |
| Products | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent… |
| Initiation date | Sep 7, 2018 |
| Report date | Oct 16, 2019 |
| Termination date | Jun 29, 2022 |
| City | Dieren |
| Country | Netherlands |
| FEI number | 3001576181 |
At a glance
- 1–9 Products in this recall
- 1–9 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: