Nanosphere, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 43
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Nanosphere, Inc. makes
Nanosphere, Inc. manufactures nucleic acid tests for infectious disease detection, including respiratory viruses, Gram-negative bacteria, *Clostridioides difficile*, and enteric pathogens. Their portfolio also covers genetic testing for pharmacogenetics (e.g., CYP2C19, F2, F5, MTHFR) and cystic fibrosis (CFTR). Tests are designed for use on their proprietary Verigene System, enabling rapid molecular diagnostics in clinical settings.
All listed devices fall under Class II regulatory classification in the U.S. and are authorised via 510(k) clearance through the FDA. The company is based in the United States.
Catalogue
Search and filter all 43 devicesCompany details
- DUNS number
- 164757242
- [email protected]
- Phone
- 888-837-4436
FDA recalls
FDA recall records list 12 recalls initiated by NANOSPHERE, INC., the earliest on 2008-02-25 and the most recent on 2014-07-09. By recorded status: 12 terminated. The reasons filed fall into these groups: labeling or instructions for use, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2014
- 9 Jul 2014 Z-2236-2014 Class II Terminated Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
- 17 Apr 2014 Z-2170-2014 Class II Terminated Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as "IVD". Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Ca
- 18 Mar 2014 Z-2559-2014 Class III Terminated Nanosphere has recieved reports related to an unacceptable increase in initial no-call rate when performing the Verigene CYP2C19 Nucleic Acid Test (2C19), which has been confirmed through internal testing.
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2013
- 16 Oct 2013 Z-2168-2014 Class III Terminated Nanosphere has received report of an increased rate of "No Call - INT CTL 2" results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
- 10 Oct 2013 Z-2681-2014 Class II Terminated Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
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- 10 Oct 2013 Z-2682-2014 Class II Terminated Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
Full distribution text
- 10 Oct 2013 Z-2683-2014 Class II Terminated Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
Full distribution text
- 10 Oct 2013 Z-2684-2014 Class II Terminated Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
Full distribution text
- 10 Oct 2013 Z-2685-2014 Class II Terminated Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in Tip Holder Assemblies for the following products and lots of Extraction Trays.
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- 17 Jun 2013 Z-2735-2014 Class II Terminated There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Full distribution text
Show all 12 recalls
2013
- 17 Jun 2013 Z-2736-2014 Class II Terminated There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Full distribution text
- 17 Jun 2013 Z-2736-2014 Class II Terminated There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
2008
- 25 Feb 2008 Z-1383-2008 Unclassified (pre-2012) Terminated Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).
Full distribution text
- 25 Feb 2008 Z-1383-2008 Unclassified (pre-2012) Terminated Aberrant Results: A warfarin 2C9*2 mutant capture signal was found to be high enough to result in an aberrant result (i.e., wild-type called heterozygous).
Frequently asked questions
How many devices does NANOSPHERE, INC. have in the registry?
The registry currently lists 43 devices for NANOSPHERE, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list NANOSPHERE, INC.'s devices?
Among its 43 most recently registered devices, NANOSPHERE, INC. has devices listed in FDA 510(k) (16 devices) and FDA GUDID (27 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do NANOSPHERE, INC.'s devices fall under?
Among its 43 most recently registered devices, the classes recorded for NANOSPHERE, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for NANOSPHERE, INC.?
FDA recall records list 12 recalls initiated by NANOSPHERE, INC., the most recent initiated on 2014-07-09. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from NANOSPHERE, INC. in the registry?
The most recently registered devices listed for NANOSPHERE, INC. include Enteric Pathogens (EP) Amplification Tray 20-011-023, Enteric Pathogens (EP) Extraction Tray 20-009-023, Respiratory Virus Plus (RV+) Extraction Tray 20-009-020 and Clostridium difficile (CDF) Nucleic Acid Test Cartridge 20-006-022.