Device recall
Z-2315-2010: E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003)…
FDA device recall · Class II · AdvanDx, Inc.
Key facts
| Recall number (Z-number) | Z-2315-2010 |
|---|---|
| Recall event | 56064 |
| Product | E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid… |
| Product code | OAH |
| Recalling firm | AdvanDx, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2011 |
| 510(k) numbers | K083074 |
| 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