Device recall
Z-2644-2014: JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a…
FDA device recall · Class III · Biofire Defense
Key facts
| Recall number (Z-number) | Z-2644-2014 |
|---|---|
| Recall event | 69032 |
| Product | JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The software and instrument… |
| Product code | NHT |
| Recalling firm | Biofire Defense |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 24, 2016 |
| 510(k) numbers | K131930 |
| FEI number | 3010770794 |
At a glance
- 1–9 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