Siemens healthcare diagnostics has confirmed the hemoglobin a1c_3/ a1c_3m reagent kit lots 230 ((b)(4)) and 231( (b)(4)) 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.An urgent medical device correction (umdc) chc-15-19 is being sent to us customers and a urgent field safety notice (ufsn) chc-15-19 is being sent to (b)(6) customers in september of 2015.The umdc and ufsn state that customers are to discontinue use and discard reagent kit lots 230 and 231.
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