Biofire Defense is recalling 130 kits of the FilmArray NGDS Warrior Panel (model NGDS-ASY-0007), which is a diagnostic test used with the FilmArray 2.0 system. The recall was initiated because these kits have an increased risk of internal control failures when testing positive blood cultures. This failure can result in invalid test runs, leading to delayed medical results and requiring laboratories to perform additional diagnostic workup for patients.
When the test's internal controls fail, the device cannot provide a valid result, potentially delaying the diagnosis of blood infections. For critically ill patients, this delay can lead to a postponement of necessary treatment or result in unnecessary medical procedures while waiting for valid results.
Qualitative, multiplexed, nucleic acid-based in vitro diagnostic test for use with the FilmArray 2.0 system.
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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