Device recall
Z-2219-2017: Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences…
FDA device recall · Class II · Exact Sciences Corporation
Key facts
| Recall number (Z-number) | Z-2219-2017 |
|---|---|
| Recall event | 77260 |
| Product | Exact Sciences Sample Mixer 2. For In Vitro Diagnostic Use. The Exact Sciences Sample Mixer 2 is intended for mixing stool samples in a Sample Container as part of pre-analytic sample processing for in vitro diagnostic tests |
| Product code | PHP |
| Recalling firm | Exact Sciences Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2017 |
| PMA numbers | P130017 |
| FEI number | 3008256118 |
At a glance
- None 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