Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

Recall date

November 13, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1326-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

US Nationwide. Global Distribution.

Why it was recalled

The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137