Z-2315-2010

E.faecalis/OE PNA FISH

Name: Z-2315-2010 E.faecalis/OE PNA FISH
Creator: AdvanDx, Inc.
Published: 2010-06-08
License: https://open.fda.gov/license/

Advandx, Inc. / initiated 2010-06-08 / Terminated / root cause: design

FDA source

AdvanDx, Inc. began a recall of 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... on 2010-06-08. The reason FDA records is "Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2315-2010
Status: Terminated
Initiated: 2010-06-08
Posted: 2010-08-31
Terminated: 2011-06-06
Recalling firm: Advandx, Inc.
Product: 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 and is compatible with all major blood culture media
Product code: OAH Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Reason for recall: Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.
Root cause tag: design
FDA 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 in their inventory with the enclosed Package Insert (revision C). Note: All shipments of E. faecalis/OE PNA FISH, as of June 14, 2010, will contain this new package insert. If you have any questions or requests for further information, please contact AdvanDx Technical Support at US (Toll Free): 1-800-376-0009 or email [email protected].
Quantity in commerce: 541 units
Distribution: Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
Product codes and lots: Catalog number KT003

Product code OAH

K083074Class IAvandx E. Faecalis/oe Pna Fish Culture Identification KitAdvandx, Inc. / cleared 2009-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)