Device recall
Z-1548-2015: Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the…
FDA device recall · Class II · Dako North America Inc.
Key facts
| Recall number (Z-number) | Z-1548-2015 |
|---|---|
| Recall event | 70898 |
| Product | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro diagnostic use. The TRD is intended to distribute patient case, appropriate parts information, track changes, and transform test requests from LIS or manual… |
| Product code | KPA |
| Recalling firm | Dako North America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2015 |
| FEI number | 2022180 |
At a glance
- None 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