FDA recall Z-1115-2025

Beckman Coulter, Inc. · Class II · device

Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

Reason for recall

A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.

Key facts

Status: Completed
Initiation date: 2024-01-03
Report date: 2025-02-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1115-2025