Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Beckman Coulter IRISpec CA/CB/CC control Recalled by Beckman Coulter, Inc. Due to IRISpec CA failures for glucose.

Date: February 16, 2022
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

Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.

Quantity: 12,306 kits

Why Was This Recalled?

IRISpec CA failures for glucose.

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