FDA-Device2025-07-02Class II
DxI 9000 Access Immunoassay Analyzer C11137
Hazard
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
Sold states
Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire, Croatia, Czechia, France, Germany, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Libya, New Zealand, Oman, Poland, Portugal, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom of Great Britain and Northern Ireland.
Affected count
67 US; 178 OUS
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer C11137
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2025More Beckman Coulter, Inc. recalls
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