Safety Alert for advia chemistry systems hemoglobin a1c_3 & a1c_3m reagent kits

Safety alert

2015-10-02

2015-10-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151002c.html

Medical device safety alert: siemens advia chemistry systems hemoglobin a1c_3 & a1c_3m reagent kits medical device manufacturer, siemens healthcare diagnostics, has issued a medical device safety alert concerning its advia chemistry systems hemoglobin a1c_3 and a1c_3m reagent kits [catalogue number: 10379673 and 10485591; lot number: 230 and 231]. the manufacturer has confirmed that the hemoglobin a1c_3 and a1c_3m kit lots listed for use on advia 1200, 1650, 1800, 2400 and xpt chemistry systems may demonstrate an increased occurrence of high %hba1c bias. the manufacturer’s 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. according to the manufacturer, 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. a positive %hba1c bias as described may be considered clinically significant at clinically relevant hba1c values, and may result in the modification of the therapy for hyperglycemia. the modification of hyperglycemic therapy can increase the risk of occurrence of hypoglycemia, which may be observed through personal glucose monitoring and/or patient symptoms. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2015.