Device recall
Z-1843-2014: FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray…
FDA device recall · Class II · BioFire Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1843-2014 |
|---|---|
| Recall event | 68352 |
| Product | FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test designed to test positive blood cultures to quickly identify the organism that is growing in the blood… |
| Product code | PAM |
| Recalling firm | BioFire Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2014 |
| 510(k) numbers | K130914 |
| 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