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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta...
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2
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09/23/2014
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Nanosphere, Inc.
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The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di...
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2
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09/23/2014
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Nanosphere, Inc.
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JBAIDS Instrument System Software version 3.5.0.72.
The JBAIDS instrument is a portable thermocyc...
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3
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09/15/2014
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Biofire Defense
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Nanosphere Verigene
Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen...
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3
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08/08/2014
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Nanosphere, Inc.
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cobas® PCR Urine Kit 100 PKT IVD
cobas® PCR Female Swab Kit 100 PKT IVD
cobas® PCR media 100T IVD
...
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2
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02/26/2014
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Roche Molecular Systems, Inc.
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BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; label...
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2
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01/17/2014
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Becton Dickinson & Co.
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MagNA Pure 96 System
Version 1.0
Software Version 2.0
Robotic workstation for automated isolati...
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2
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12/18/2013
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Roche Diagnostics Operations, Inc.
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KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD
Roche Molecular System, Inc. 1080 US highway ...
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2
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09/10/2013
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Roche Molecular Systems, Inc.
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QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223)
Product Usage: The artus CMV RG PCR A...
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2
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05/14/2013
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QIAGEN Gaithersburg, Inc.
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QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225)
Product Usage: Test is intended for u...
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2
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05/14/2013
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QIAGEN Gaithersburg, Inc.
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