United StatesRevogene C. difficile in vitro diagnostic assay for use with the Revogene instrument (Catalog Number 410300, UDI‑DI 00840733102349; lots 410300U195, 410300U196, 410300U197, 410300U201) is being recalled by Meridian Bioscience Inc; 211 units were distributed in the United States and Italy. The affected lots show a decline in performance over time that may lead to false-negative results.
What's being recalled
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Recalling firm: Meridian Bioscience Inc, Cincinnati, OH, United States.
How to identify it
UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
The hazard
The affected lots show a decline in performance over time, which may lead to false-negative results.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution and the OUS country of Italy.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)