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Beckman Coulter, Inc. recalls Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Recalled July 31, 2024 · FDA recall Z-2414-2024 · Beckman Coulter
Hazard
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results. · FDA Class II
Units
143 devices
Sold at
Worldwide - US Nationwide distribution in the states of FL, IN, KS, NH, PA, and TX. The countries of Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.
Description
The analyzers were built with nonconforming USB cables made with brass contacts instead of specified gold contacts. Brass contacts may corrode over time, leading to loss of internal instrument communication and delayed patient results.
Product
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →