Device recall
Z-1647-2013: 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1647-2013 |
|---|---|
| Recall event | 65207 |
| Product | 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry… |
| Product code | JJE |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2018 |
| 510(k) numbers | K031924 |
| FEI number | 1000136573 |
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