| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00922-1 |
| Product Name/Description |
Haemoglobin A1c (HbA1c) Flex Reagent Cartridge (An in vitro diagnostic medical device (IVD) used with Dimension Vista Systems)
Siemens Material Number (SMN): 10470481
Catalogue Number: K3105A
All in-date lot numbers are affected
ARTG Number: 181689 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed that when whole blood samples are run from Small Sample Container (SSC – KS860 SMN 10472099)), HbA1c values may exhibit a percent bias ranging from -8.2% to +6.5% compared to results from the primary container. The percent bias range is a percentage of the HbA1c result; it is NOT % HbA1c units. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens Healthcare Diagnostics is advising customer not to use Small Sample Containers (SSC) when running whole blood samples with Dimension Vista HbA1c assay and to process HbA1c samples according to the Instructions For Use for Primary Tubes or Sample Cups i.e. samples should be mixed by inversion (gently invert the tube ten times) or in a rocker mixer to obtain uniform distribution of erythrocytes prior to testing. Users are also advised that the need for a look back at previously reported results should be discussed with the laboratories Medical Director. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |