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All Recalls

Every Nanosphere, Inc. Recall

Sorted by most recent. Click any recall for full details.

9 recalls
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded w...
Diagnostic Devices·1,045 affected·Jul 9, 2014
High RiskFDA
Nanosphere, Inc.
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative mu...
Diagnostic Devices·580 affected·Apr 17, 2014
RecallFDA
Nanosphere, Inc.
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 ...
Medical Devices·78 affected·Mar 18, 2014
RecallFDA
Nanosphere, Inc.
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. ...
Diagnostic Devices·280 affected·Oct 16, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of...
Medical Devices·220 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended ...
Respiratory Devices·780 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection...
Diagnostic Devices·80 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitativ...
Diagnostic Devices·400 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tes...
Diagnostic Devices·20 affected·Jun 17, 2013