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AdvanDx, Inc. recalls AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: Q
Recalled January 8, 2014 · FDA recall Z-0619-2014 · AdvanDx
Hazard
Kits incompatible with certain fluorescence microscope light sources · FDA Class III
Units
49 kits US; 17 kits OUS
Sold at
Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
Description
Kits incompatible with certain fluorescence microscope light sources
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
Manufacturer(s)
AdvanDx, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →