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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
Recalled July 2, 2025 · FDA recall Z-1996-2025 · Beckman Coulter
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. · FDA Class II
Units
67 US; 178 OUS
Sold at
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.
Description
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.
Product
DxI 9000 Access Immunoassay Analyzer C11137
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →