Device recall
Z-0873-2015: HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-0873-2015 |
|---|---|
| Recall event | 69663 |
| Product | HemoCue Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual… |
| Product code | CGA |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 2, 2015 |
| 510(k) numbers | K020935 |
| FEI number | 1523456 |
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