Device recall
Z-0112-2013: AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture…
FDA device recall · Class II · Advandx Inc
Key facts
| Recall number (Z-number) | Z-0112-2013 |
|---|---|
| Recall event | 63215 |
| Product | AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the… |
| 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