Clostridium difficile (CDF) Extraction Tray 20-009-022

• • Ongoing Z-2024-2023 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-2010-2021 FDA Class II ·initiated 30 Oct 2020 ·via K123197, on the same 510(k)

  Potential for a false-negative result.

• • Terminated Z-2168-2014 FDA Class III ·initiated 16 Oct 2013

  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.

• • Terminated Z-2682-2014 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

Clostridium difficile (CDF) Extraction Tray

Generic Name

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

Model / Reference

20-009-022

Primary DI / UDI-DI

00857573006256

510(k) Number

K123197 ↗

FDA Product Code

OZN

GMDN Term

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

Device Class

Class II

Regulation Number

866.3130

Commercial Distribution

Not in Commercial Distribution

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