Nanosphere, Inc.
Medical device manufacturer in Northbrook, IL.
15510(k) clearances
0PMA approvals
12recalls
Device types
- OCC Respiratory Virus Panel Nucleic Acid Assay… 6
- ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug… 1
- NSU Instrumentation For Clinical Multiplex Test… 1
- NUA System, Cystic Fibrosis Transmembrane… 1
- NQX System, Nucleic Acid Amplification Test… 1
- PAM Gram-Positive Bacteria And Their Resistance… 1
- NTI Drug Metabolizing Enzyme Genotyping Systems 1
- OZN C. Difficile Toxin Gene Amplification Assay 1
- PEN Gram-Negative Bacteria And Associated… 1
- PCH Gastrointestinal Pathogen Panel Multiplex… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K143653 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)OCC · Traditional | 09/04/2015SE |
| K140083 | Verigene Enteric Pathogen Nucleic Acid Test ( Ep)PCH · Traditional | 06/20/2014SE |
| K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)PEN · Traditional | 01/08/2014SE |
| K123197 | Verigene C. Difficile Nucleic Acid Test (CDF)OZN · Traditional | 12/05/2012SE |
| K120466 | Verigene CYP2C19 Nucleic Acid Tes (2C19)NTI · Traditional | 11/06/2012SE |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | 09/19/2012SE |
| K112424 | Verigene Staphylococcus Blood Culture Nucleic Acid Test (Bc-S)NQX · Traditional | 12/16/2011SE |
| K103209 | Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)OCC · Traditional | 01/10/2011SE |
| K093337 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP SystemOCC · Special | 11/17/2009SE |
| K092957 | Verigene System, Verigene Respiratory Virus Nucleic Acid TestOCC · Special | 10/21/2009SE |
| K092566 | Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (Rvnatsp)OCC · Traditional | 10/09/2009SE |
| K083294 | Verigene CFTR Nucleic Acid Test and Verigene CFTR Polyt Nucleic Acid TestNUA · Traditional | 07/24/2009SE |
| K083088 | Verigene Respiratory Virus Nucleic Acid TestOCC · Traditional | 05/01/2009SE |
| K070597 | Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNSU · Traditional | 10/11/2007SE |
| K070804 | Verigene System, Verigene Warfarin Metabolism Nucleic Acid TestODW · Traditional | 09/17/2007SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2236-2014 Class II | Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test…Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene… | 07/09/2014Terminated |
| Z-2170-2014 Class II | Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the…Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk… | 04/17/2014Terminated |
| Z-2559-2014 Class III | Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20…Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing… | 03/18/2014Terminated |
| Z-2168-2014 Class III | Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a…Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal… | 10/16/2013Terminated |
| Z-2685-2014 Class II | The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2684-2014 Class II | The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2683-2014 Class II | The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2682-2014 Class II | The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2681-2014 Class II | The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the…Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures… | 10/10/2013Terminated |
| Z-2736-2014 Class II | Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges…There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process… | 06/17/2013Terminated |
| Z-2735-2014 Class II | Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges…There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process… | 06/17/2013Terminated |
| Z-1383-2008 | Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro…Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an… | 02/25/2008Terminated |