Approximately 99,822 BIOFIRE Blood Culture Identification 2 (BCID2) Panels are being recalled when used with specific BACT/ALERT Culture Media Bottles. The diagnostic panels may provide false positive results for Serratia marcescens bacteria because of the presence of non-living organisms in certain lots of the culture media bottles. If a false positive result occurs, healthcare providers might unknowingly prescribe inappropriate antibiotics or make unnecessary changes to a patient's medical therapy. Consumers and clinical laboratories should contact their manufacturer or healthcare provider for specific guidance on identifying affected lots and interpreting results.
The highly sensitive test can detect non-viable bacteria within the media bottles, triggering an incorrect positive result. This poses a risk of improper medical treatment, such as a patient receiving the wrong medication or discontinuing a necessary treatment based on inaccurate diagnostic data.
Manufacturer guidance and clinical notification.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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