Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay

Issue

Siemens Healthineers has confirmed, through internal investigation of customer complaints, the potential for intermittent well-to-well bias affecting the A1c_E/A1c_H assay when used on the Atellica CH and Atellica CI systems. This observed bias does not affect every A1c_E reagent lot or reagent pack. However, affected wells cannot currently be identified prospectively, therefore all in-date lots are considered potentially impacted until further notice. Under certain circumstances, this issue may result in:. Falsely depressed patient results when lot calibration is performed using an affected well and patient testing is subsequently performed using an unaffected well.. Falsely elevated patient results when lot calibration is performed using an unaffected well and patient testing is subsequently performed using an affected well.