FDA-Device2025-03-26Class II
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Beckman Coulter, Inc.
Hazard
the DxI 9000 encoder wheel was misaligned on the motor shaft, leading to increased slippage errors and causing the instrument to stop, posing a high safety risk due to potential delays in patient results.
Sold states
US Nationwide. Global Distribution.
Affected count
206 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, 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-1388-2025Don't want to check this manually?
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