Device recall
Z-2899-2026: GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004…
FDA device recall · Class II · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-2899-2026 |
|---|---|
| Recall event | 99128 |
| Product | GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at… |
| Product code | CHL |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K223608 |
| 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