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Alethia™ C. difficile

MERIDIAN BIOSCIENCE, INC. · Model 480050 · UDI-DI 00840733102172

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Alethia™ C. difficile DNA amplification assay, performed on the Alethia™ Instrument, is a qualitative in vitro diagnostic test for the direct detection of toxigenic C. difficile in human stool specimens from pediatric and adult patients suspected of having Clostridium difficile-associated disease (CDAD). The Alethia™ C. difficile assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect the pathogenicity locus (PaLoc) of toxigenic Clostridium difficile. The Clostridium difficile PaLoc is a gene segment present in all known toxigenic C. difficile strains. The C. difficile PaLoc codes for both the Toxin A gene (tcdA) and the Toxin B gene (tcdB), has conserved border regions, and is found at the same site on the C. difficile genome for all toxigenic strains. The Alethia™ C. difficile assay detects the PaLoc by targeting a partial DNA fragment on the Toxin A gene. The tcdA target region was selected as an intact region remaining in all known A+B+ and A-B+ toxinotypes.

Recalls

Date	Firm	Reason
2025-10-07	Meridian Bioscience Inc	The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
2014-04-22	Meridian Bioscience Inc	Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.

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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.