Recall Z-0112-2013— Advandx Inc

Class II FDA medical device recall by Advandx Inc, initiated 2012-09-14, terminated 2013-03-05. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva.

Recalling firm

Advandx Inc

Classification

Class II

Status

Terminated

Initiated

2012-09-14

Terminated

2013-03-05

Firm location

Woburn, MA, United States

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