Class II — Potential Health Hazard

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

DxI 9000 Access Immunoassay Analyzer Recalled by Beckman Coulter, Inc. Due to Ground screws on Dxl 9000 PCB boards may...

Date: July 12, 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

DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids

Quantity: 30 OUS

Why Was This Recalled?

Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.

Where Was This Sold?

OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.

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