Beckman Coulter, Inc. recalls Access 2 Immunoassay Analyzer, Catalog Number 81600N

Recall date

February 5, 2025

Source

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

Recall number

Z-1386-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Worldwide - US Nationwide distribution.

Why it was recalled

Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test 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

Access 2 Immunoassay Analyzer, Catalog Number 81600N