Beckman Coulter, Inc.: Device Recall

Recall #Z-1388-2025 · 02/05/2025

Class II: Risk

Recall Details

Recall Number: Z-1388-2025
Classification: Class II
Product Type: Device
Recalling Firm: Beckman Coulter, Inc.
Status: Ongoing
Date Initiated: 02/05/2025
Location: Chaska, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 206 units

Reason for Recall

the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.

Product Description

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

Distribution Pattern

US Nationwide. Global Distribution.

Other Recalls by Beckman Coulter, Inc.

Class II: Risk 12/23/2025

Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
Class II: Risk 11/26/2025

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Class II: Risk 11/26/2025

Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Class II: Risk 11/10/2025

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Class II: Risk 11/07/2025

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

View all recalls by Beckman Coulter, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.