Device recall
Z-1118-2008: Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test…
FDA device recall · Class II · Innovacon Inc
Key facts
| Recall number (Z-number) | Z-1118-2008 |
|---|---|
| Recall event | 45911 |
| Product | Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121. |
| Product code | JHI |
| Recalling firm | Innovacon Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 12, 2011 |
| 510(k) numbers | K062361 |
| FEI number | 3005689981 |
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