Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01297-1
Product Name/Description	Dimension Vista Systems - Cyclosporine (CSA) Flex reagent cartridge. An in vitro diagnostic medical device (IVD) Catalogue Number: K4089 Lot Numbers: 12300BB, 12318BB and 13011BB ARTG Number: 182779
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	5/12/2013
Responsible Entity	Siemens Ltd Diagnostics Division
Reason/Issue	Siemens Healthcare Diagnostics has received complaints regarding variability in recovery of QC and patient results with the Dimension Vista CSA Flex reagent cartridge lots 12300BB, 12318BB, and 13011BB. Investigation by Siemens confirms that the performance of these lots are atypical, and internal testing observed increases of >25% over several days for cyclosporine results in samples with CSA concentrations below 125 ng/mL. Daily QC checks can detect performance variations in this assay.
Recall Action	Recall
Recall Action Instructions	Siemens is advising users to discontinue use and discard remaining inventory. Siemens recommends that the communication is reviewed by the Laboratory Director, a review of previously generated results is at the discretion of the laboratory.
Contact Information	1800 310 300 - Siemens Technical Support Centre