Recall Z-0491-2011 ยท JSS Kit, Identification, Enterobacteriaceae
AdvanDx, Inc.
AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia (In-Vitro Diagnostic) Catalog number: KT008 EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made from p
| Date | Dec 1, 2010 (initiated Oct 8, 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 sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert. For questions regarding this recall contact Advan |
| Quantity | 27 kits |
| Distribution | Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092393 | EK/P. AERUGINOSA PNA FISH Advandx, Inc., Sep 1, 2009 |