Siemens Healthcare Diagnostics has recalled 9,729 Atellica CH Reaction Ring Cuvette Segments (Siemens Material Number 11099326) due to a manufacturing defect. These cuvette segments may cause inaccurate lab results—either too high or too low—for several critical tests, including Ammonia, Acetaminophen, Hemoglobin A1c, and others. While no injuries have been reported, faulty results could lead to incorrect medical diagnoses or treatment decisions for patients.
The defect causes imprecision in the incubation and measurement process for seven specific analytes. This can result in erroneously depressed or elevated results for patient samples and quality control checks, potentially leading to medical mismanagement.
All lots starting with N15 on the packaging or 15 on the underside of the cuvette segment are expected to have the defect.
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.
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Sources: FDA iRES · Raw API Response
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