Device recall
Z-2165-2011: Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000…
FDA device recall · Class II · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-2165-2011 |
|---|---|
| Recall event | 58060 |
| Product | Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument… |
| Product code | CGA |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K093623 |
| FEI number | 1217183 |
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