FDA-Device2024-09-04Class II

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.

Hazard

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

Sold states

Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom of Great Britain and Northern Ireland.

Affected count

183 analyzers

Manufactured in

1000 Lake Hazeltine Dr, Chaska, MN, United States

Products

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2735-2024

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