Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1019-2026 — Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

U.S. FDA — Device Enforcement · United States · 2025-12-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1019-2026
Date of alert
2025-12-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Meridian Bioscience Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840733102349
Reported risk: The affected lots show a decline in performance over time, which may lead to false-negative results.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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