Beckman Coulter, Inc. recalls Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibrati…

Recall date

November 7, 2025

Source

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

Recall number

Z-0889-2026

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

US Nationwide. Global Distribution.

Why it was recalled

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.

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 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901