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U.S. Department of Health and Human Services

Class 3 Device Recall AdvanDx GramNegative QuickFISH BC

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  Class 3 Device Recall AdvanDx GramNegative QuickFISH BC see related information
Date Initiated by Firm December 11, 2013
Date Posted January 02, 2014
Recall Status1 Terminated 3 on January 13, 2014
Recall Number Z-0619-2014
Recall Event ID 67069
510(K)Number K123418  
Product Classification Kit, identification, enterobacteriaceae - Product Code JSS
Product AdvanDx Gram-Negative QuickFISH BC.
In-Vitro Diagnostic for the identification of Enterobacteriacae
Catalog Number: QFGNRBC1-25

Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Code Information Lot codes US: 04813C, 7413, 08113 exp. 2013-12  Lot codes OUS: 03113A 04213A 04813B
Recalling Firm/
Manufacturer		 AdvanDx, Inc.
10a Roessler Rd
Woburn MA 01801-6208
For Additional Information Contact
781-376-0009
Manufacturer Reason
for Recall		 Kits incompatible with certain fluorescence microscope light sources
FDA Determined
Cause 2		 Process design
Action AdvanDx issued an email notification along with a PDF file of the new package insert to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or techwupport@advandx.com. For questions regarding this recall call 781-376-0009.
Quantity in Commerce 49 kits US; 17 kits OUS
Distribution Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
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 = JSS and Original Applicant = ADVANDX, INC.
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