Device recall
Z-2805-2011: GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75…
FDA device recall · Class I · Instrumentation Laboratory Co.
Key facts
| Recall number (Z-number) | Z-2805-2011 |
|---|---|
| Recall event | 58996 |
| Product | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM Part Number: 00027407509 150 test iQM Part Number: 00027415009 300 test iQM Part Number: 00027430009 450 test iQM Part Number: 00027445009 600 test iQM Part Number: 00027360009 The GEM Premier 4000 is a portable… |
| Product code | CEM |
| Recalling firm | Instrumentation Laboratory Co. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 27, 2012 |
| 510(k) numbers | K061974, 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