Device recall
Z-0824-2012: HemoCue Glucose 201 Microcuvettes, Article…
FDA device recall · Class III · Hemo Cue, Inc.
Key facts
| Recall number (Z-number) | Z-0824-2012 |
|---|---|
| Recall event | 60539 |
| Product | HemoCue Glucose 201 Microcuvettes, Article Number:110705*,110706,110715**,110716**,110717**,110718**, 110719** " No affected lots of this article have been delivered to customers. Still in stock at distributor HemoCue Inc. "" Article not available in US Quantitative determination of glucose in whole… |
| Product code | CGA |
| Recalling firm | Hemo Cue, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 2, 2012 |
| 510(k) numbers | K020935 |
| FEI number | 3005104838 |
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