Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro… — Class II medical device recall Z-1647-2014
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-05-28, distributed nationwide. A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples
| Recall number | Z-1647-2014 |
|---|---|
| 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 | 2014-03-19 |
| Classified | 2014-05-21 |
| Reported by FDA | 2014-05-28 |
| Terminated | 2015-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, DE, ES, FR, GB, IT, JP, SA |
| Quantity | 4,175 |
| Expiration dates | 2014-04-24, 2014-06-06, 2014-09-03, 2014-09-06, 2014-11-13, 2015-01-08, 2015-02-19 |
Product
Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients.
Reason for recall
A complaint was received of Dimension Vista¿ CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44%. In March 2014, Siemens recalled due to the complaint received of Dimension Vista¿ CSA and CSAE reporting under-recovery of cyclosporine when patient samples are run from the Small Sample C
Machine access
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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.