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Clostridium difficile (CDF) Nucleic Acid Test Cartridge

NANOSPHERE, INC. · Model 20-006-022 · UDI-DI 00857573006157

OZN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).

Recalls

Date	Firm	Reason
2025-12-05	Meridian Bioscience Inc	The affected lots show a decline in performance over time, which may lead to false-negative results.
2025-09-23	Becton Dickinson & Co.	Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar
2024-10-31	Becton Dickinson & Co.	BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv
2023-06-05	Luminex Corporation	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) co
2022-06-17	Luminex Corporation	There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
2019-02-20	Luminex Corporation	Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially
2013-10-16	Nanosphere, Inc.	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 CD
2013-10-10	Nanosphere, Inc.	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 f

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.