Device recall
Z-0594-2007: Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of…
FDA device recall · Class II · Inverness Medical Professional Diagnostics
Key facts
| Recall number (Z-number) | Z-0594-2007 |
|---|---|
| Recall event | 37356 |
| Product | Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma. Product No. 61100KVC 10 test devices containing anti D-dimer monoclonal antibody and sheep anti-mouse antibody 1 x 2.6 mL buffer containing 0.9% sodium chloride and 0.05% sodium… |
| Product code | GHH |
| Recalling firm | Inverness Medical Professional Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 8, 2007 |
| 510(k) numbers | K993276 |
| FEI number | 3003764480 |
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