FDAMarch 7, 2016device

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 rutheni...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

03000079190

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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