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U.S. Department of Health and Human Services

Class 2 Device Recall E.faecalis/OE PNA Fish

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  Class 2 Device Recall E.faecalis/OE PNA Fish see related information
Date Initiated by Firm June 08, 2010
Date Posted August 31, 2010
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-2315-2010
Recall Event ID 56064
510(K)Number K083074  
Product Classification fish (fluorescent in situ hybridization) kit, protein nucleic acid, enterococcus faecalis - Product Code OAH
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
Code Information Catalog number KT003
Recalling Firm/
Manufacturer		 AdvanDx, Inc.
10a Roessler Rd
Woburn MA 01801-6208
For Additional Information Contact same
781-376-0009
Manufacturer Reason
for Recall		 Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.
FDA Determined
Cause 2		 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 techsupport@advandx.com.
Quantity in Commerce 541 units
Distribution Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OAH and Original Applicant = ADVANDX, INC.
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