Recall Z-2315-2010 ยท OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
AdvanDx, Inc.
E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures. E. faecalis/OE PNA FISH provides rapid identification of E. faecalis and selected other enterococci (OE) on smears made from positive blood cultures
| Date | Aug 31, 2010 (initiated Jun 8, 2010) |
| Status | Terminated |
| Reason | Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal. |
| Root cause | Device Design |
| Action | The firm, AdvanDx, sent a letter dated June 8, 2010, and email notification on June 11, 2010, to all customers. The letter described the product, problem and action to be taken by customers. AdvanDx notified the customers that there was a change to the package insert under "limitations" to include the statement "some strains of Streptococcus anginosus produce a false green positive fluorescence due to sequence similarities and enclosed a package insert for all E. facealis/OE PNA FISH (KT003) kits. The customers were instructed to replace the Package Insert (revision B) included with any kits |
| Quantity | 541 units |
| Distribution | Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083074 | AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT Advandx, Inc., Jul 24, 2009 |