FDA-Device2025-02-12Class II
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
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-1115-2025More Beckman Coulter, Inc. recalls
- FDA-Device2026-04-15Beckman Coulter MicroScan Neg MIC 3J antibiotic susceptibility panels recalled for manufacturing defects
- FDA-Device2026-04-15MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
- FDA-Device2026-04-01Beckman Coulter MicroScan Neg MIC 56 panels recalled for potential well contamination
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