Device recall
Z-0491-2011: AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification…
FDA device recall · Class II · AdvanDx, Inc.
Key facts
| Recall number (Z-number) | Z-0491-2011 |
|---|---|
| Recall event | 56997 |
| Product | AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for… |
| Product code | JSS |
| Recalling firm | AdvanDx, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2011 |
| 510(k) numbers | K092393 |
| FEI number | 3004080598 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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