| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00334-1 |
| Product Name/Description |
Dimension Vista Cyclosporine (CSA) Flex Reagent Cartridge and Dimension Vista Cyclosporine (CSAE) Flex Reagent Cartridge
Dimension Vista CSA:
Catalogue Number: K4089
Siemens Material Number: 10445139
Lot Numbers: 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BB
Dimension Vista CSAE:
Catalogue Number: K4108
Siemens Material Number: 10445142
Lot Numbers: 13157BC & 13429BD
ARTG Number: 182779 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
18/03/2014 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has received a complaint for under-recovery of patient samples with the Dimension Vista CSA Flex reagent cartridge when whole blood samples are run from Small Sample Container (SSC). Investigations by Siemens have confirmed that CSA, as well as CSAE, under-recovers by 18% to 44% when whole blood samples are run from SSC. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising end users to cease using small Sample Containers when running whole blood samples with Dimension Vista CSA and CSAE assays. A review of previously reported results is recommended for cyclosprine samples run in Small Sample Containers. This action has been closed-out on 01/02/2016. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |