Gram-Negative Blood Culture (BC-GN) Utility Tray 20-011-021

• • Ongoing Z-1109-2022 FDA Class II ·initiated 15 Feb 2022 ·on shared 510(k) K132843

  Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

• • Ongoing Z-2008-2021 FDA Class II ·initiated 30 Oct 2020 ·on shared 510(k) K132843

  Potential for a false-negative result.

• • Completed Z-1903-2025 FDA Class II ·initiated 16 Apr 2025

  It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

• • Terminated Z-2776-2020 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-2236-2014 FDA Class II ·initiated 9 Jul 2014

  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.

• • Terminated Z-2170-2014 FDA Class II ·initiated 17 Apr 2014

  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

• • Terminated Z-2681-2014 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-2736-2014 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.

Trade Name

Gram-Negative Blood Culture (BC-GN) Utility Tray

Generic Name

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Model / Reference

20-011-021

Primary DI / UDI-DI

00857573006300

510(k) Number

K132843 ↗

FDA Product Code

PEN

GMDN Term

Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

Device Class

Class II

Regulation Number

866.3365

GUDID distribution status

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

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