FDA Device recall Z-1241-2016
Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test…
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test… by Siemens Healthcare Diagnostics, citing the drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1241-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-13 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
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
The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1241-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.