BioFire Diagnostics, LLC is recalling 29 kits of the FilmArray Pneumonia Panel plus (Pneumoplus), reference number RFIT-LBL-0374. This diagnostic test is being recalled due to an increased risk of internal control failures and false negative test results. While no injuries or incidents have been reported, a false negative result could lead to a delay in the correct diagnosis and treatment of pneumonia. Laboratories and healthcare providers should stop using the affected lot immediately and contact the manufacturer to arrange for a return or replacement.
The diagnostic test may fail to detect pathogens or fail its internal quality controls, resulting in a false negative. This creates a risk that a patient with pneumonia might not receive necessary medical treatment or might receive incorrect treatment based on the inaccurate test result.
Recall number Z-1518-2025; 29 kits affected.
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.
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Sources: FDA iRES · Raw API Response
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