Device product
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
Z-0818-2014
Product summary
- Event
- Event 67057
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1586
- Official record key
device-enforcement:Z-0818-2014
Official wording
Reason: Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Code information: lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014.
Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada.
Derived failure modes
-
Unknown
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.