FDAFDA · Food and drugs·Recall number Z-0619-2014
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
Published January 8, 2014 · Recall initiated: December 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Kits incompatible with certain fluorescence microscope light sources
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AdvanDx, Inc.
- Distributor
- Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
- Lot
- Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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