Device recall
Z-0524-2009: IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with…
FDA device recall · Class II · Siemens Medical Solutions Diagnostics
Key facts
| Recall number (Z-number) | Z-0524-2009 |
|---|---|
| Recall event | 49077 |
| Product | IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta. |
| Product code | JLS |
| Recalling firm | Siemens Medical Solutions Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2012 |
| 510(k) numbers | K944211 |
| FEI number | 3005250747 |
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