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 Revogene C. difficile assay is used to diagnose C. difficile infections, which can lead to severe gastrointestinal issues. Healthcare providers rely on accurate test results for effective treatment.
The decline in performance over time may prevent the assay from detecting the presence of C. difficile, resulting in false-negative results. This could lead to misdiagnosis and lack of essential treatment for patients.
This recall is not part of a broader industry pattern.
Consumers may face health risks due to potential misdiagnosis. Delayed treatment for C. difficile infections can lead to serious health complications.
The catalog and lot numbers are typically found on the product packaging or on the label attached to the assay.
Expect a refund processing timeline of approximately 4-6 weeks after returning the product.
Keep records of your product details, receipts, and any correspondence with the manufacturer regarding the recall.
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.
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