Meridian Bioscience Inc has recalled 211 units of its Revogene C. difficile in vitro diagnostic assay (Catalog Number 410300) because the test may show a decline in performance over time. This issue affects four specific lots of the assay used with the Revogene instrument. When the performance of the test drops, it can result in false-negatives, meaning it might fail to detect the presence of C. difficile in a patient sample.
A false-negative result can lead to a delay in diagnosis and treatment for a Clostridioides difficile infection. This can cause the patient's condition to worsen and increases the risk of the infection spreading to others in a clinical or hospital environment.
Intended for use with the Revogene instrument.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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