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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 Siemens Ltd Diagnostics Division
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