Device recall
Z-1849-2011: HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative…
FDA device recall · Class II · Hemo Cue, Inc.
Key facts
| Recall number (Z-number) | Z-1849-2011 |
|---|---|
| Recall event | 57602 |
| Product | HEMOCUE AB Hb 201 DM ANALYZER, in vitro diagnostic device for quantitative hemoglobin determination. |
| Product code | GKR |
| Recalling firm | Hemo Cue, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2011 |
| 510(k) numbers | K041234 |
| FEI number | 3005104838 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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