Device recall
Z-0832-2015: HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A…
FDA device recall · Class II · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-0832-2015 |
|---|---|
| Recall event | 69824 |
| Product | HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The… |
| Product code | GJS |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2016 |
| 510(k) numbers | K060931 |
| FEI number | 1217183 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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