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FDA-Device2024-08-21Class II

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Beckman Coulter, Inc.
Hazard

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, and TX. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
Affected count
183 devices
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2024

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