Device recall
Z-0086-2014: HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm…
FDA device recall · Class II · HemoCue AB
Key facts
| Recall number (Z-number) | Z-0086-2014 |
|---|---|
| Recall event | 65918 |
| Product | HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low… |
| Product code | KQO |
| Recalling firm | HemoCue AB |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2014 |
| 510(k) numbers | K053253 |
| 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