Abbott Laboratories recalls The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.

Recall date

March 24, 2016

Source

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

Recall number

Z-1865-2016

FDA classification

Class II

Brand / firm

Abbott Laboratories

Sold / distributed

Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUS…

Why it was recalled

Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.

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

What was recalled

The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.