| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01393-1 |
| Product Name/Description |
Haemoglobin A1c (HbA1c) Flex reagent cartridge used with Dimension Vista with software version 3.6.2 or higher. An in vitro diagnostic medical device (IVD)
Assay: Dimension Vista HbA1C
Catalogue Number: K3105A
Siemens Material Number: 10470481
ARTG Number: 181689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has previously confirmed that when whole blood samples are run from the Small Sample Container (SSC), the HbA1c value may contain a percent bias range of - 8.2% to + 6.5% (TGA Ref: RC-2014-RN-00922-1). Due to this bias, use of the SSC was withdrawn. As a follow up Siemens Healthcare Diagnostics has confirmed that the SSC can now be used with the Dimension Vista Haemoglobin A1c (HbA1c) assay with software version 3.6.2 or higher. The HbA1c Instructions For Use beginning with lot 17205BA will detail use of the SSC. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that samples for the HbA1c method can be assayed from a Small Sample Container (SSC) loaded in a “Surplus” sample rack and processed as Routine or STAT.
When using an SSC, pipette a minimum of 400 uL of the whole blood sample and load in a “Surplus” sample rack using a 13mm tube insert (Do not run from a “Limited” sample rack).
This action has been closed out on 3/09/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |