Drug recall
AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia…
FDA recall event 63215 · Class II · Advandx Inc
Key facts
| Event ID | 63215 |
|---|---|
| Recall numbers | Z-0112-2013 |
| Recalling firm | Advandx Inc |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva |
| Initiation date | Sep 14, 2012 |
| Report date | Oct 31, 2012 |
| Termination date | Mar 5, 2013 |
| City | Woburn |
| State | MA |
| Country | United States |
| FEI number | 3008179799 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: