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FDA-Device2024-02-14Class II

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

Beckman Coulter, Inc.
Hazard

There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.

Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Affected count
128 analyzers
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2024

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