Device recall
Z-0244-2008: Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List…
FDA device recall · Class II · Applied Biotech Inc
Key facts
| Recall number (Z-number) | Z-0244-2008 |
|---|---|
| Recall event | 44894 |
| Product | Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ… |
| Product code | JHI |
| Recalling firm | Applied Biotech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2012 |
| 510(k) numbers | K992187 |
| FEI number | 1000125390 |
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