Siemens Healthcare Diagnostics, Inc. has initiated a voluntary recall of approximately 11,330 units of Atellica CH β2-Microglobulin (B2M) reagent. The recall was issued because the reagent may produce falsely low results when testing samples that require automatic dilution, specifically those with protein levels between 18.00 mg/L and 30.00 mg/L. This product is a laboratory diagnostic tool used to measure protein levels in human serum and plasma to help monitor various health conditions. No incidents or injuries have been reported to date.
A falsely depressed test result can lead to incorrect medical diagnoses or inappropriate patient management, as the true concentration of β2-microglobulin would be higher than reported. This inaccuracy could potentially mask the progression of certain medical conditions that the test is intended to monitor.
Siemens Material Number (SMN): 11097635. All in-date and future Atellica CH B2M reagent lots are included.
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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