Device recall
Z-1963-2009: BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244…
FDA device recall · Class II · BD Diagnostics (GeneOhm Sciences, Inc)
Key facts
| Recall number (Z-number) | Z-1963-2009 |
|---|---|
| Recall event | 52107 |
| Product | BD Diagnostics, BD GeneOhm MRSA Assay, REF: 441242 (200 Reaction Kit) and 441244 (48 Reaction Kit). For the rapid detection of methicillin resistant MRSA DNA in nasal specimen. |
| Product code | NQX |
| Recalling firm | BD Diagnostics (GeneOhm Sciences, Inc) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2011 |
| 510(k) numbers | K042357 |
| FEI number | 3004788834 |
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