Dimension Vista Cyclosporine Flex reagent cartridge an in vitro… — Class II medical device recall Z-0818-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-01-29, distributed nationwide. Complaints were received regarding variability in recovery of QC and patient results with certain lots of the
| Recall number | Z-0818-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2013-12-05 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-08-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,586 |
| Lot numbers | 12300BB, 12318BB, 13011BB |
| Expiration dates | 2013-10-26, 2013-11-13, 2014-01-11 |
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 for recall
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0818-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.