Device recall
Z-2174-2010: BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD…
FDA device recall · Class III · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-2174-2010 |
|---|---|
| Recall event | 55813 |
| Product | BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended for use as an aid in diagnosis of CDAD. |
| Product code | LLH |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 15, 2010 |
| 510(k) numbers | K081920 |
| 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