Atellica CH Enzymatic Hemoglobin A1c (A1c_E) assay

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.