FDA recall Z-2414-2024

Beckman Coulter, Inc. · Class II · device

Product

Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137.

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.

Key facts

Status
Ongoing
Initiation date
2024-06-04
Report date
2024-07-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2414-2024