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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative,
Recalled September 11, 2024 · FDA recall Z-1546-2024 · Beckman Coulter
Hazard
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment. · FDA Class II
Units
17 units
Sold at
Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.
Description
Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
Product
DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →