Nanosphere, Inc.

12 FDA 510(k) clearances · Recalling firm

Record	Firm	Date
Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are recall (Z-2735-2014)	Nanosphere, Inc.	2014-09-30
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are recall (Z-2736-2014)	Nanosphere, Inc.	2014-09-30
The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sa recall (Z-2681-2014)	Nanosphere, Inc.	2014-09-23
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed i recall (Z-2682-2014)	Nanosphere, Inc.	2014-09-23
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sam recall (Z-2683-2014)	Nanosphere, Inc.	2014-09-23
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qu recall (Z-2684-2014)	Nanosphere, Inc.	2014-09-23
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test f recall (Z-2685-2014)	Nanosphere, Inc.	2014-09-23
Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigen recall (Z-2559-2014)	Nanosphere, Inc.	2014-08-28
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Ca recall (Z-2236-2014)	Nanosphere, Inc.	2014-08-14
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a V recall (Z-2168-2014)	Nanosphere, Inc.	2014-08-08
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample recall (Z-2170-2014)	Nanosphere, Inc.	2014-08-08
Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diag recall (Z-1383-2008)	Nanosphere, Inc.	2008-03-31

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Every clearance here is in the API, with alerts when new ones post.