Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.17 and below that may cause delayed patient test results due to error messages when connected to lab systems.
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.
Take action
Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter DxI 9000 Access Analyzer Software Risk: Delayed Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55035-beckman-coulter-dxi-9000-access-analyzer-software-risk-delayed-test. Based on FDA recall #Z-2544-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2544-2024%22&limit=1).
The FDA announced on May 22, 2024, that Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to software errors that may delay patient test results. The agency issued recall number Z-2544-2024 for the device.
How to tell if you have it
Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer
Catalog #: C11137
Software versions: 1.17 and below
UDI-DI: 15099590732103
The hazard
According to the FDA, when connected to a Laboratory Automation System (LAS) and running software versions 1.17 or below, the analyzer may send an "out of sequence" message upon receiving a sample tube. This issue can result in multiple error messages, such as a sample pick and place error or a "no result obtained" flag, creating a risk of delays in processing patient test results and treatment.
Context
GovInfoNow's records show Beckman Coulter has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026). Additional similar recalls include the Beckman Coulter DxC 700 AU Recall (Jan. 30, 2026), the Beckman Coulter AU5800 Chemistry Analyzer Recall (Jan. 30, 2026), and the AU480 Chemistry Analyzer recall (Aug. 3, 2026).
How to tell if you have this one
Check if your analyzer has software version 1.17 or older. The product includes catalog number C11137 and UDI-DI 15099590732103.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Check if your analyzer has software version 1.17 or older and update to a newer version if available.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Indiana, Kansas, Maine, New Hampshire, New Jersey, Oklahoma, Pennsylvania, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2544-2024 (May 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2544-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.