ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes). An in vitro diagnostic medical device (IVD). 의 리콜

Recall

RC-2016-RN-00983-1

Class II

2016-07-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00983-1

The system also allows reporting in either ngsp units (hba1c% = %) or ifcc units (hba1cr = mmol/mol). the ratio equation used to calculate advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results in ifcc units contains an error. the error results in falsely depressed hba1cr results. available data indicates results may be depressed up to -62% (with an average of -18%). this issue does not impact hba1cr results using manual pre-treatment or ngsp units.Falsely depressed results may be considered clinically significant at clinically relevant hba1c values. the risk to health is limited to a potential misinterpretation of glycaemic control or a delay in assessing long-term average hyperglycaemia. when this issue occurs, the potential discordance between average glycaemia and falsely depressed hba1c values may be observed through personal glucose monitoring and/or patient symptoms.

Siemens is recommending retesting of patients with results above 35 mmol/mol that have been generated in the past 4 months and recommends discussing this issue with the laboratory director. Customers running the currently running the assay using Automated Pre-treatment and reporting results in IFCC units (mmol/mol) are advised to immediately discontinue reporting HbA1cR results. Siemens will be replacing the affected TDef disk with a corrected disk.