BioFire Diagnostics, LLC is recalling 82 units of its BIOFIRE FILMARRAY Pneumonia Panel and Pneumonia Panel plus diagnostic kits due to a manufacturing process defect. This issue causes an increased risk of internal control failures, which prevents the device from delivering a test result. This defect results in delayed diagnostic information for patients being tested for pneumonia. The affected products were distributed in Alabama, Indiana, and West Virginia, as well as several countries internationally, and have expiration dates in late August 2024.
A manufacturing error makes these diagnostic panels more likely to fail their internal quality checks. When a control fails, the panel cannot provide a valid result, potentially leading to significant delays in the diagnosis and treatment of serious respiratory infections.
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Sources: FDA iRES · Raw API Response
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