Device recall
Z-1662-2013: BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in…
FDA device recall · Class III · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-1662-2013 |
|---|---|
| Recall event | 65431 |
| Product | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings. |
| Product code | NJR |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 19, 2013 |
| 510(k) numbers | K111860 |
| FEI number | 1119779 |
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