Class II — Potential Health Hazard

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

Access Total T4 Recalled by Beckman Coulter, Inc. Due to Four lots of Access Total T4 reagent lots...

Date: February 8, 2024
Company: Beckman Coulter, Inc.
Status: Ongoing
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 Beckman Coulter, Inc. directly.

Affected Products

Access Total T4, REF 33800, IVD, thyroxine reagent assay.

Quantity: 64,009 kits

Why Was This Recalled?

Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Beckman Coulter, Inc.

Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.

Related Recalls

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