Approximately 2,061 kits of BD SARS-CoV-2 Reagents for BD MAX Systems have been recalled because they may produce false negative results. This issue is caused by decreased activity of an enzyme used during manufacturing, which means the test might not detect the virus even when it is present. These kits are RT-PCR tests used with nasal, nasopharyngeal, oropharyngeal, and saliva specimens. If you were tested using one of these kits, you should contact your healthcare provider to discuss the results and the possibility of retesting.
A false negative result can lead to a delayed diagnosis or inappropriate treatment for COVID-19. This poses a risk of further spreading the virus to others if the infected individual does not take necessary isolation precautions based on an incorrect test result.
Manufacturer-initiated voluntary recall for enzyme activity issues.
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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