Company: Beckman Coulter, Inc.
Date of Enforcement Report: 2/06/2025
Class II
PRODUCT
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Recall Number:
Z-1115-2025
REASON:
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
RECALLING FIRM/MANUFACTURER:
Beckman Coulter, Inc.
VOLUME OF PRODUCT IN COMMERCE:
61 units
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.
