Device recall
Z-0101-2017: cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-0101-2017 |
|---|---|
| Recall event | 75186 |
| Product | cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein… |
| Product code | JQP |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 5, 2017 |
| FEI number | 1823260 |
At a glance
- None Linked 510(k)s
- 10–99 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