Class II — Potential Health Hazard

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

BECKMAN COULTER IRISpec CA/CB/CC control Recalled by Beckman Coulter, Inc. Due to Beckman Coulter has become aware of an increase...

Date: November 18, 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, REF 900-7211, For in vitro diagnostic use only.

Quantity: 3657 units

Why Was This Recalled?

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

Where Was This Sold?

US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan

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