Meridian Bioscience recalled 211 units of the Revogene C. difficile diagnostic assay on December 5, 2025. Users may experience false-negative results due to a decline in performance over time. Patients and healthcare providers must stop using the device immediately.
The affected lots show a decline in performance over time, which may lead to false-negative results.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Meridian Bioscience Inc or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Revogene C. difficile in vitro diagnostic assay with Catalog Number 410300. It was distributed nationwide in the US and in Italy. The affected lot numbers are 410300U195, 410300U196, 410300U197, and 410300U201.
The affected lots may show a decline in performance over time, which can result in false-negative results for C. difficile infections. This poses a significant risk to patient health, as incorrect results may lead to a lack of necessary treatment.
No specific incidents or injuries have been reported related to this recall. However, the potential for false-negative results could lead to untreated infections.
Stop using the Revogene C. difficile assay immediately. Follow the manufacturer’s recall instructions. Contact Meridian Bioscience Inc or your healthcare provider for further instructions.
For more information, contact Meridian Bioscience Inc at their customer service line or visit their website for detailed recall instructions.
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