FDA Device recall Z-0818-2014
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in…
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in… by Siemens Healthcare Diagnostics, citing complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0818-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-05 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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.
Reason
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Identifiers
| code_info | lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0818-2014%22
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