Device recall
Z-0790-2014: BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes…
FDA device recall · Class II · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-0790-2014 |
|---|---|
| Recall event | 66933 |
| Product | BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative… |
| Product code | LLH |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 19, 2014 |
| 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