Cepheid is recalling 4,132 units of its Xpert SA Nasal Complete kit (Catalog Number GXSACOMP-10) due to the risk of false negative test results. This diagnostic tool is used in laboratories to detect the presence of methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria in nasal samples. The issue was discovered during stability testing when a known positive sample incorrectly tested negative, suggesting the test's reliability decreases over time.
A false negative result means a patient could be infected with MRSA or MSSA, but the test will incorrectly report that they are not. This can lead to delayed treatment for a serious infection and may prevent hospitals from implementing the necessary isolation procedures to stop the bacteria from spreading to other patients.
Intended for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.