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Verigene C. Difficile Nucleic Acid Test (Cdf)

by Nanosphere, Inc. 510(k)

Active United States

510(k) K123197

Regulatory status

as of 27 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123197 Date5 Dec 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

4 recalls · 2 ongoing · FDA

    • 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.

Specification

510(k)

510(k) Number
FDA Product Code
OZN
Device Class
Class II
Regulation
21 CFR Part 866.3130
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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