Device recall
Z-0827-2018: BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and…
FDA device recall · Class II · Siemens Healthcare Diagnostics
Key facts
| Recall number (Z-number) | Z-0827-2018 |
|---|---|
| Recall event | 79053 |
| Product | BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC Thrombin Reagent Kit Lot Number 47184; UDI -008427680131024718420190221; BC Thrombin Reagent; Test, Thrombin Time Product Usage: For in vitro diagnostic use. Reagent for the quantitative determination of the thrombin… |
| Product code | GJA |
| Recalling firm | Siemens Healthcare Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 4, 2019 |
| 510(k) numbers | K970645 |
| FEI number | 2432235 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database