Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The ARCHITECT Estradiol Kit Intended to measure estradiol Recalled by Abbott Laboratories Due to Interaction of Fulvestrant with the ARCHITECT Estradiol assay,...

Date: March 24, 2016
Company: Abbott Laboratories
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories directly.

Affected Products

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

Quantity: 39,346 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 42 states: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY

Affected (42 states)Not affected

About Abbott Laboratories

Abbott Laboratories has 124 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report