Device recall
Z-0116-2013: AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture…
FDA device recall · Class II · Advandx Inc
Key facts
| Recall number (Z-number) | Z-0116-2013 |
|---|---|
| Recall event | 63199 |
| Product | AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia… |
| Product code | JSS |
| Recalling firm | Advandx Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2013 |
| FEI number | 3004080598 |
At a glance
- None 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