Z-1241-2016Class II

Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099

Name: Z-1241-2016 Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099
Creator: Siemens Healthcare Diagnostics, Inc
Published: 2016-01-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-01-13 / Terminated / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc began a 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 for the... on 2016-01-13. FDA classified it as Class II and gives the reason as "The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1241-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-13
Posted: 2016-03-24
Terminated: 2018-01-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
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 VistaSystem. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Product code: CHP Radioimmunoassay, Estradiol
Reason for recall: The drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.
Root cause tag: design
FDA root cause: Device Design
Action: Siemens issued an Urgent Medical Device Correction (UMDC) to affected Siemens Healthcare Diagnostics customers in the United States on January 13, 2016 to be delivered to customers on January 14, 2016 via Federal Express. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 13, 2016. The letters identified affected product, problem and the actions to be taken. Customers may continue to use the estradiol assays to report patient results however, the assays should not be used for patients being treated with fulvestrant. Customers where instructed to complete and return the Correction Effectiveness Check attached. For questions contact your Siemens Customer Care Center or your local Siemens technical support representative.
Quantity in commerce: 1945 units
Distribution: Worldwide Distribution US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1241-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1240-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24
Z-1241-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24
Z-1242-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24
Z-1243-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code CHP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)