Class II — Potential Health Hazard

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

Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Recalled by Abbott Ireland Diagnostics Division Due to Patient results may be falsely elevated. This patient...

Date: February 5, 2019
Company: Abbott Ireland Diagnostics Division
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 Ireland Diagnostics Division directly.

Affected Products

Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma.

Quantity: 2,724

Why Was This Recalled?

Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Ireland Diagnostics Division

Abbott Ireland Diagnostics Division has 12 total recalls tracked by RecallDetector.

Related Recalls

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