Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid Test

• • Ongoing Z-2533-2024 FDA Class II ·initiated 20 Jun 2024

  Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

• • Ongoing Z-0500-2024 FDA Class II ·initiated 7 Nov 2023

  Potentially defective utility trays in the reagent kits.

• • Ongoing Z-2007-2021 FDA Class II ·initiated 30 Oct 2020 ·on shared 510(k) K122514

  Potential for a false-negative result.

• • Terminated Z-2775-2020 FDA Class II ·initiated 15 Jun 2020

  An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.

• • Terminated Z-0822-2019 FDA Class III ·initiated 26 Dec 2018

  On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.

• • Terminated Z-0445-2019 FDA Class II ·initiated 14 Sep 2018

  Potential to lead to a false negative results.

• • Terminated Z-2683-2014 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.

• • Terminated Z-2735-2014 FDA Class II ·initiated 17 Jun 2013

  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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K122514 ↗

FDA Product Code

PAM

Device Class

Class II

Regulation

21 CFR Part 866.3365

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• 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

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