09

Aug

2024

FDA Recall: Multiple Error Messages Result When Running Software Versions 1.17 and Below

0

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 8/9/2024
Class II

PRODUCT

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

Recall Number:

Z-2544-2024

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Beckman Coulter, Inc.

VOLUME OF PRODUCT IN COMMERCE:

183 devices

DISTRIBUTION:

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, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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