Enteric Pathogens (EP) Nucleic Acid Test Cartridge 20-006-023

• • Ongoing Z-2023-2023 FDA Class II ·initiated 5 Jun 2023

  It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.

• • Ongoing Z-2451-2021 FDA Class II ·initiated 3 Aug 2021

  There is potential for false positive results.

• • Ongoing Z-1488-2021 FDA Class II ·initiated 18 Mar 2021

  Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.

• • Ongoing Z-2009-2021 FDA Class II ·initiated 30 Oct 2020 ·via K140083, on the same 510(k)

  Potential for a false-negative result.

• • Terminated Z-2685-2014 FDA Class II ·initiated 10 Oct 2013

  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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

Enteric Pathogens (EP) Nucleic Acid Test Cartridge

Generic Name

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Model / Reference

20-006-023

Primary DI / UDI-DI

00857573006041

510(k) Number

K140083 ↗

FDA Product Code

PCI, PCH

GMDN Term

Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray

Device Class

Class II

Regulation Number

866.3990

Commercial Distribution

Not in Commercial Distribution

• Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn) Open recall

  Class II

  FDA 510(k) K132843 Active Cleared 8 Jan 2014

• Verigene Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATSP)

  Class II

  FDA 510(k) K092566 Active Cleared 9 Oct 2009

• Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test

  Class II

  FDA 510(k) K070804 Active Cleared 17 Sep 2007

• Verigene C. Difficile Nucleic Acid Test (Cdf) Open recall

  Class II

  FDA 510(k) K123197 Active Cleared 5 Dec 2012

• Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+)

  Class II

  FDA 510(k) K103209 Active Cleared 10 Jan 2011

• Verigene Enteric Pathogen Nucleic Acid Test (EP) Open recall

  Class II

  FDA 510(k) K140083 Active Cleared 20 Jun 2014

See all devices from Nanosphere, Inc. →