Device recall
Z-2824-2026: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog…
FDA device recall · Class II · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-2824-2026 |
|---|---|
| Recall event | 99115 |
| Product | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Product Description: The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and… |
| Product code | CHL |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203790 |
| 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