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Revogene C. difficile

MERIDIAN BIOSCIENCE, INC. · Model 410300 · UDI-DI 00840733102349

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Revogene C. difficile assay performed on the Revogene instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection. The Revogene C. difficile assay is intended to aid in the diagnosis of 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.