Dimension Vista¿ Calcium Flex¿ reagent cartridge — Class II medical device recall Z-1540-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-05-09, distributed nationwide. May produce erroneously low results from specific well sets.
| Recall number | Z-1540-2018 |
|---|---|
| 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 | 2018-01-30 |
| Classified | 2018-04-27 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-05-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, DK, ES, FR, IT, JP, KR, NO, PT, SI, SK |
| Quantity | 6,000 |
| Lot numbers | 17171BD |
| Expiration dates | 2018-06-20 |
Product
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Reason for recall
May produce erroneously low results from specific well sets.
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-1540-2018. 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.