Cepheid is recalling 10,357 Xpert BCR-ABL Ultra in-vitro diagnostic test kits, specifically models GXBCRABL-US-10 and GXBCRABL-10. This recall was initiated because the test kits may produce inaccurate results when used with patient specimens that have an elevated white blood cell count of more than 30,000 cells. Laboratory professionals and healthcare providers should check their inventory against the affected lot numbers to identify these specific diagnostic kits.
Using these test kits on specimens with high white blood cell counts can lead to incorrect diagnostic readings. Inaccurate test results may lead to improper clinical management or flawed treatment decisions for patients.
Quantity: 6325 units
Quantity: 4032 units
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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