Siemens Healthcare Diagnostics is recalling approximately 94,949 units of several Atellica CH reagents used with the Atellica CH 930 analyzer. The affected products include Total Bilirubin_2 (TBil_2), LDL Cholesterol (LDLC), Gamma-Glutamyl Transferase (GGT), and HDL Cholesterol (HDLC). The recall was initiated because of a technical defect where reagent carryover causes a 'positive bias,' meaning test results for patients, quality control, and calibrators may be inaccurately high. Consumers and laboratory staff should contact Siemens or their healthcare provider regarding these inaccurate diagnostic results.
Reagent carryover can cause the analyzer to report higher-than-actual levels of bilirubin, cholesterol, and enzymes in patient blood samples. These inaccurate laboratory results could lead to incorrect medical diagnoses, unnecessary follow-up testing, or inappropriate treatment decisions by physicians.
Technical mitigation and healthcare provider consultation
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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