Device recall
Z-1948-2016: Ariol is an automated scanning microscope and image analysis system. It is…
FDA device recall · Class III · Leica Biosystems Richmond Inc.
Key facts
| Recall number (Z-number) | Z-1948-2016 |
|---|---|
| Recall event | 74178 |
| Product | Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol… |
| Product code | NQN |
| Recalling firm | Leica Biosystems Richmond Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 13, 2017 |
| 510(k) numbers | K031715, K033200, K043519 |
| FEI number | 1419341 |
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