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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Detail

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
Recall Number Z-0619-2014
Classification Class III
Code Info Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
Product Distributed Qty 49 kits US; 17 kits OUS
Reason For Recall Kits incompatible with certain fluorescence microscope light sources

Event Detail

Event Id 67069
Product Type Devices
Status Ongoing
Recalling Firm AdvanDx, Inc.
City Woburn
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.