Recall Z-1277-2016— Roche Diagnostics Operations, Inc.

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2016-03-07, terminated 2018-01-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.

Recalling firm

Roche Diagnostics Operations, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-03-07

Terminated

2018-01-10

Firm location

Indianapolis, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.