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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