Device recall
Z-0083-2012: Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a…
FDA device recall · Class II · Data Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-0083-2012 |
|---|---|
| Recall event | 52105 |
| Product | Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen… |
| Product code | JQP |
| Recalling firm | Data Innovations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2011 |
| 510(k) numbers | BK080052 |
| FEI number | 3001451449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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