Device recall
Z-0226-2009: BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro…
FDA device recall · Class II · BD Diagnostics (GeneOhm Sciences, Inc)
Key facts
| Recall number (Z-number) | Z-0226-2009 |
|---|---|
| Recall event | 49470 |
| Product | BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test performed on… |
| Product code | NQX |
| Recalling firm | BD Diagnostics (GeneOhm Sciences, Inc) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2010 |
| 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