Hemoglobin A1c_3 (A1c_3 and A1c_3M) Reagent Lots 에 대한 현장 안전성 서한

Field Safety Notice

Slovenia

AMPMDRS

Siemens healthcare diagnostics has confirmed the hemoglobin a1c_3/ a1c_3m reagent kit lots listed in table 1 used on the advia® 1200, 1650, 1800, 2400, and xpt chemistry systems may demonstrate an increased occurrence of high %hba1c bias. siemens internal investigation demonstrates reagent lots 230 and 231 may exhibit a positive bias averaging 0.6% hba1c units, ranging from -0.1% to 1.1% hba1c units. the bias was observed when comparing %hba1c means to ngsp pooled patient target-value assigned samples ranging from approximately 5.5% to 8.0% hba1c. the maximum bias was observed at higher %hba1c concentrations. qc samples may exhibit a similar bias. .