Recall Z-0116-2013— 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 E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.. Reason: Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal.

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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