FDA-Device2025-03-19Class II
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Beckman Coulter, Inc.
Hazard
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Sold states
US Nationwide. Global Distribution.
Affected count
245 units
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1326-2025Don't want to check this manually?
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