| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00983-1 |
| Product Name/Description |
ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. An in vitro diagnostic medical device (IVD)
(used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes).
Siemens Material Numbers: 11127343 and 11222123
ARTG Number: 175890 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
The system also allows reporting in either NGSP units (HbA1c% = %) or IFCC units (HbA1cR = mmol/mol). The ratio equation used to calculate ADVIA Chemistry Haemoglobin 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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed out on the 26/10/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |