Cepheid has recalled 9,880 units of the Xpert MTB/RIF diagnostic test, model number GXMTB/RIF-US-10. This recall was issued because the product failed to meet stability criteria during testing. The affected units belong to batch 1000812229 and lot 41302, with an expiration date of February 2, 2025.
Failure to meet stability standards means the test may not perform correctly over its shelf life, potentially leading to inaccurate results when testing for tuberculosis or drug resistance. Inaccurate diagnostic data can lead to improper patient treatment or delays in providing necessary medical care.
Product testing did not meet expected stability criteria.
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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