Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Recall date

March 27, 2025

Source

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

Recall number

Z-1664-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Worldwide distribution.

Why it was recalled

When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.

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

What was recalled

Beckman Coulter DxI 9000 Access Immunoassay Analyzer