Advandx Recalls
4 recalls on record · October 31, 2012 to August 13, 2014 · Medical Devices
Recalls by year
12
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 13, 2014Medical DevicesFDA
Advandx Inc recalls AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are
Hazard: Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
January 8, 2014Medical DevicesFDA
AdvanDx, Inc. recalls AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: Q
Hazard: Kits incompatible with certain fluorescence microscope light sources
October 31, 2012Medical DevicesFDA
Advandx Inc recalls AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudom
Hazard: 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
October 31, 2012Medical DevicesFDA
Advandx Inc recalls AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebs
Hazard: GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva