Device recall
Z-2673-2011: Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000…
FDA device recall · Class II · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-2673-2011 |
|---|---|
| Recall event | 58878 |
| Product | Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Premier 3500 blood gas analyzer is a portable system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting. The instrument provides… |
| Product code | CHL |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2013 |
| 510(k) numbers | K052121 |
| FEI number | 1217183 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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