Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463… — Class II medical device recall Z-1241-2016
Terminated recall by Siemens Healthcare Diagnostics, Inc, reported 2016-03-30, distributed nationwide. The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
| Recall number | Z-1241-2016 |
|---|---|
| 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 | 2016-01-13 |
| Classified | 2016-03-24 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2018-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,945 units |
| Model numbers | 10489099, K6463 |
Product
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Reason for recall
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
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.