Recall Z-0490-2011 ยท JSS Kit, Identification, Enterobacteriaceae
AdvanDx, Inc.
AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007
| Date | Nov 29, 2010 (initiated Oct 6, 2010) |
| Status | Terminated |
| Reason | Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal. |
| Root cause | Device Design |
| Action | AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert. Customers can contact AdvanDx technical support about this action at 1-866-376-0009. |
| Quantity | 260 units |
| Distribution | Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092236 | E.COLI/P. AERUGINOSA PNA FISH Advandx, Inc., Dec 16, 2009 |