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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Recalled March 26, 2025 · FDA recall Z-1388-2025 · Beckman Coulter
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. · FDA Class II
Units
206 units
Sold at
US Nationwide. Global Distribution.
Description
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.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →