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 %(b)(6) bias.Siemens internal investigation demonstrates reagent lots 230 and 231 may exhibit a positive bias averaging 0.6% (b)(6) units, ranging from -0.1% to 1.1% (b)(6) units.The bias was observed when comparing %(b)(6) means to ngsp pooled patient target-value assigned samples ranging from approximately 5.5% to 8.0% (b)(6).The maximum bias was observed at higher %(b)(6)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 ous 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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