Siemens Healthcare Diagnostics is recalling 21,291 units of its Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay because they may produce inaccurate, depressed results when processed on the same analyzer as the Atellica CH RCRP test. This issue involves 9,750 units in the United States and 11,541 units internationally. The error can worsen over time, potentially showing false negatives or skewed data during Quality Control (QC) checks. Healthcare providers using these specific analyzers should contact Siemens to resolve the technical bias.
Inaccurate A1c results can lead to a delay in diagnosing diabetes or result in less-than-optimal treatment plans for patients with existing diabetes. The defect causes a negative bias and imprecision that is not consistent with the laboratory instructions for use.
Impacted only when processed on the same analyzer as Atellica CH RCRP.
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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