BioFire Diagnostics, LLC is recalling 32,910 units of the BIOFIRE Blood Culture Identification 2 (BCID2) Panel used with specific quality control materials. The recall was initiated because changes in the control panel or instrument characteristics can cause the test to incorrectly report a 'Not Detected' result for Candida tropicalis, even when the fungus is actually present in the sample. This occurs because the test's signal falls outside the narrow technical limits set for a positive result. If you are a healthcare provider or laboratory using these diagnostic panels, please contact your manufacturer representative for guidance on amended testing procedures.
A false negative result for Candida tropicalis may lead to delayed or inappropriate treatment for patients with blood infections. This can result in serious health complications if the underlying fungal infection is not correctly identified and treated by medical professionals.
Amended testing and quality control procedures
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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