Device recall
Z-1956-2011: Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1956-2011 |
|---|---|
| Recall event | 57990 |
| Product | Coulter GEN's The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a semi-automated reticulocyte analysis. |
| Product code | GKL |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2012 |
| 510(k) numbers | K962988 |
| FEI number | 2050012 |
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