Dimension Vista LOCI Progesterone — Class II medical device recall Z-1419-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2017-03-15, distributed nationwide. DHEA-S causes falsely elevated progesterone results.
| Recall number | Z-1419-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc, East Walpole, MA, United States |
| Recall initiated | 2017-01-04 |
| Classified | 2017-03-09 |
| Reported by FDA | 2017-03-15 |
| Terminated | 2019-07-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,148 |
| Model numbers | K6464 |
Product
Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems
Reason for recall
DHEA-S causes falsely elevated progesterone results.
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-1419-2017. 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.