Siemens Healthcare Diagnostics, Inc. has recalled 8,721 units of the Atellica CH Iron3 reagent used in Atellica CH and Atellica CI laboratory analyzers. The recall was initiated because using this reagent can cause subsequent tests in the same equipment (specifically Cholesterol, LDL Cholesterol, and Triglycerides) to produce falsely elevated results by 2% to 16%. This issue affects patient results, quality control measures, and calibrators, potentially leading to incorrect medical interpretations of a patient's lipid profile.
The defect causes chemical carryover in the analyzer's cuvettes, resulting in a positive bias that makes cholesterol and triglyceride levels appear higher than they actually are. This could lead to unnecessary medical treatments or misdiagnosis of cardiovascular risks for patients.
Manufacturer notification and technical instruction
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.
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Sources: FDA iRES · Raw API Response
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