Z-1277-2016Class II

Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT...

Name: Z-1277-2016 Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT...
Creator: Roche Diagnostics Operations, Inc.
Published: 2016-03-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2016-03-07 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL... on 2016-03-07. FDA classified it as Class II and gives the reason as "Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will...". 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-1277-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-07
Posted: 2016-03-31
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
Product: Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium complex 2.75 ng/mL Product Usage: Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Product code: CHP Radioimmunoassay, Estradiol
Reason for recall: Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e
Root cause tag: design
FDA root cause: Device Design
Action: Roche sent an Urgent Medical Device Correction letter dated March 7, 2016 via UPS Ground (receipt required) to the consignee list. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to complete the attached fax form and fax it to 1-866-891-1984. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336.
Quantity in commerce: 102,312
Distribution: US Nationwide Distribution including Puerto Rico.
Product codes and lots: Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1277-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1277-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

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)