| Class 2 Device Recall AdvanDx GNR Traffic Light PNA FISH |  |
Date Initiated by Firm | September 14, 2012 |
Date Posted | October 22, 2012 |
Recall Status1 |
Terminated 3 on March 05, 2013 |
Recall Number | Z-0112-2013 |
Recall Event ID |
63215 |
Product Classification |
Kit, identification, enterobacteriaceae - Product Code JSS
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Product | AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa
Catalog number: KT011.
GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia. |
Code Information |
Lot Numbers: 02012A-US Exp. Date: 4-2014; 0812A-US Exp. Date: 12-2013; 01212A-EU Exp. Date: 4-2012 00712A-EU Exp. Date: 12-2013 |
Recalling Firm/ Manufacturer |
Advandx Inc 400 Tradecenter Ste 6990 Woburn MA 01801
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Manufacturer Reason for Recall | GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva |
FDA Determined Cause 2 | Device Design |
Action | AdvanDx sent a "GNR Traffic Light PNA FISH (KT011) Package Insert Replacement" letter dated September 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received an Acknowledgement Form to complete and return to AdvanDx so that the effectiveness of the replacement can be evaluated. Contact AdvanDx Technical Support at 1-866-376-0009 for questions regarding this notice. |
Quantity in Commerce | 187 kits |
Distribution | Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK. |
Total Product Life Cycle | TPLC Device Report |
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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.
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