Device recall
Z-1065-2019: Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1…
FDA device recall · Class II · Accelerate Diagnostics Inc
Key facts
| Recall number (Z-number) | Z-1065-2019 |
|---|---|
| Recall event | 82216 |
| Product | Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1, PSW000012B Product Usage: The Accelerate Pheno system is intended to measure signal intensity of fluorescent probes bound to nucleic acid in target and non-target organisms and to take time-lapse dark-field images of… |
| Product code | PRH |
| Recalling firm | Accelerate Diagnostics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2021 |
| FEI number | 3010671651 |
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