FDA-Device2025-03-26Class II
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Hazard
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.
Sold states
Worldwide - US Nationwide distribution in the states of FL, TX, WA.
Affected count
80 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1387-2025More 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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