Class II — Potential Health Hazard

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

AU5800 Chemistry Analyzers Recalled by Beckman Coulter Inc. Due to Beckman coulter has received complaints regarding leaking and...

Date: July 30, 2015
Company: Beckman Coulter Inc.
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 Beckman Coulter Inc. directly.

Affected Products

AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other accessories.

Quantity: 2,130 units total (588 units in US)

Why Was This Recalled?

Beckman coulter has received complaints regarding leaking and cracked C cups. When the cup cracks, coolant can leak onto the connectors of the Printed Circuit Boards (PCB) in the analyzer, resulting in a short-circuit causing the instrument to go into a stop mode.

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 241 total recalls tracked by RecallDetector.

Related Recalls

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