FDA-Device2025-02-12Class II
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Beckman Coulter, Inc.
Hazard
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Sold states
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.
Affected count
61 units
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1115-2025Don't want to check this manually?
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