Home / Recalls / AdvanDx, Inc. / Z-0619-2014

Z-0619-2014 Class III Terminated

Recalled by AdvanDx, Inc. — Woburn, MA

Recall Details

Product Type
Devices
Report Date
January 8, 2014
Initiation Date
December 11, 2013
Termination Date
January 13, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49 kits US; 17 kits OUS

Product Description

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

Reason for Recall

Kits incompatible with certain fluorescence microscope light sources

Distribution Pattern

Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.

Code Information

Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B

Other recalls by AdvanDx, Inc.

  • Z-2138-2014 Class II — AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro dia (July 4, 2014)
  • Z-0112-2013 Class II — AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identificati (September 14, 2012)
  • Z-0116-2013 Class II — AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identificati (September 14, 2012)