FDA-Device2025-03-26Class II
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Beckman Coulter, Inc.
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-1387-2025Don't want to check this manually?
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