Device recall
Z-2627-2011: BACTEC" FX Instrument-Top, catalog #441385. The BD BACTEC" FX instrument is…
FDA device recall · Class II · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-2627-2011 |
|---|---|
| Recall event | 58873 |
| Product | BACTEC" FX Instrument-Top, catalog #441385. The BD BACTEC" FX instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly into BACTEC culture vials, which are placed into the instrument for incubation and testing. |
| Product code | MDB |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2011 |
| 510(k) numbers | K915796 |
| 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