Device recall
Z-2190-2013: HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The…
FDA device recall · Class II · HemoCue AB
Key facts
| Recall number (Z-number) | Z-2190-2013 |
|---|---|
| Recall event | 65854 |
| Product | HemoCue Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed… |
| Product code | CGA |
| Recalling firm | HemoCue AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 2, 2014 |
| 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