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Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Recalled February 12, 2025 · FDA recall Z-1115-2025 · Beckman Coulter
Hazard
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. · FDA Class II
Units
61 units
Sold at
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.
Description
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →