Device recall
Z-2070-2025: The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue…
FDA device recall · Class II · HemoCue AB
Key facts
| Recall number (Z-number) | Z-2070-2025 |
|---|---|
| Recall event | 97025 |
| Product | The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available… |
| Product code | CGA |
| Recalling firm | HemoCue AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K020935 |
| FEI number | 3003044483 |
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