Medical Device Recall: Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.
Beckman Coulter, Inc. · June 4, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
143 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2414-2024
Status: ongoing
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