FDA-Device2024-07-31Class II
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, Inc.
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.
Sold states
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.
Affected count
143 devices
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2414-2024Don't want to check this manually?
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