Diasorin Inc. recalls LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoass…

Recall date

July 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0645-2017

FDA classification

Class II

Brand / firm

Diasorin Inc.

Sold / distributed

USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq, Mongolia, Greece, Albania, Austria, Bosnia, Bosnia Herzegovina, Belarus, Bulgaria, Macedonia, Poland, Serbia…

Why it was recalled

DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON¿ Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.