Devices

Device Recall AdvanDx GramNegative QuickFISH BC

Model / Serial
Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
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
Manufacturer
AdvanDx, Inc.
1 Event
- Recall of Device Recall AdvanDx GramNegative QuickFISH BC

Manufacturer

AdvanDx, Inc.

Manufacturer Address
AdvanDx, Inc., 10a Roessler Rd, Woburn MA 01801-6208
Manufacturer Parent Company (2017)
Advandx, Inc.
Source
USFDA

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