Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1277-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 7, 2016

Date Posted: April 6, 2016

Recall Number: Z-1277-2016

Event ID: 73411

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

Status: Terminated

Product Quantity: 102,312

Code Information:

Part Number Elecsys Estradiol II : 03000079190; all lot numbers are affected.

Distribution Pattern:

US Nationwide Distribution including Puerto Rico.

Voluntary or Mandated:

Voluntary: Firm initiated