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Beckman Coulter Inc. recalls UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device us
Recalled February 26, 2014 · FDA recall Z-0985-2014 · Beckman Coulter
Hazard
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results. · FDA Class II
Units
1 unit
Sold at
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Description
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
Product
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in 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 →