Device recall
Z-1715-2008: In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for…
FDA device recall · Class II · Siemens Medical Solutions Diagnostics
Key facts
| Recall number (Z-number) | Z-1715-2008 |
|---|---|
| Recall event | 47384 |
| Product | In vitro Diagnostic-Clinitest hCG Cassette Pregnancy Test, Radio immunoassay for Human Chorionic Gonadotropin (hCG) test system Product Number: 1760 The Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in… |
| Product code | JHI |
| Recalling firm | Siemens Medical Solutions Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2012 |
| 510(k) numbers | K032563 |
| FEI number | 3002637618 |
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