BioFire Diagnostics, LLC is recalling 32,910 units of the BIOFIRE Blood Culture Identification 2 (BCID2) Panel. This diagnostic device is being recalled because it may provide false positive results for the fungus Candida tropicalis when used with specific BD BACTEC blood culture vial mediums. These false positives occur because the blood culture vials themselves likely contain non-viable DNA fragments of the fungus which the highly sensitive BioFire test then detects, even though the patient may not actually have the infection.
A false positive result could lead to a patient receiving unnecessary and potentially toxic antifungal treatments, or it could delay the search for the actual cause of a patient's illness. While both the BioFire test and the BD vials are performing as designed, their interaction in these specific combinations creates a diagnostic error that could impact clinical decision-making.
Technical notification and clinical guidance
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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