Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

Recall date

April 23, 2025

Source

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

Recall number

Z-1913-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public…

Why it was recalled

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

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, running software version 1.20