Dimension Vista¿ Calcium — Class II medical device recall Z-0039-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2016-10-12, distributed nationwide. Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 1
| Recall number | Z-0039-2017 |
|---|---|
| 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 | 2016-08-03 |
| Classified | 2016-10-04 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2017-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BS, CA, CZ, DE, DK, ES, IT, JP, KR, NL, PT, SA, SI |
| Quantity | 5,991 cartridges |
| Lot numbers | 16060BB |
Product
Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
Reason for recall
Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high 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-0039-2017. 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.