Device recall
Z-2295-2020: FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-2295-2020 |
|---|---|
| Recall event | 85550 |
| Product | FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative… |
| Product code | PEN |
| Recalling firm | BioFire Diagnostics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 14, 2021 |
| 510(k) numbers | K130914, K143171, K160457, K181493 |
| FEI number | 3002773840 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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