Device 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
Z-0619-2014
Product summary
- Firm
- AdvanDx, Inc.
- Event
- Event 67069
- Status
- Terminated
- Classification
- Class III
- Quantity
- 49 kits US; 17 kits OUS
- Official record key
device-enforcement:Z-0619-2014
Official wording
Reason: Kits incompatible with certain fluorescence microscope light sources
Code information: Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
Distribution pattern: Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
Derived failure modes
-
Unknown
Kits incompatible with certain fluorescence microscope light sources