Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software versions 1.17.0 or below due to sample timeout errors that may delay patient treatment. Affected units have specific catalog numbers and UDI-DI codes.
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.
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: Sample Timeout Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55034-beckman-coulter-dxi-9000-access-analyzer-software-risk-sample-timeout. Based on FDA recall #Z-2735-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2735-2024%22&limit=1).
The FDA announced on May 22, 2024, that Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers due to a software defect that may delay test results and patient treatment. The agency issued recall number Z-2735-2024 for the Class II voluntary recall.
How to tell if you have it
Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer
Catalog #: C11137
Software versions: 1.17.0 or below
UDI-DI: 15099590732103
The hazard
According to the FDA, when connected to a Laboratory Automation System, analyzers with software versions 1.17.0 and below may fail to signal that the sample wheel is full. This can cause test results to be flagged with a sample wheel timeout error and delay reporting, potentially leading to delayed patient treatment.
Context
GovInfoNow's records show Beckman Coulter has issued 132 other recalls since June 20, 2017. Recent similar product recalls include the AU480 Chemistry Analyzer recall on August 3, 2026, and the AU5800 Chemistry Analyzer recall on January 30, 2026.
How to tell if you have this one
Check for the catalog number C11137 and software versions 1.17.0 or below. The device also has a specific UDI-DI code 15099590732103.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Install the latest software version to fix the timeout error issue.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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,…” 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, Washington.
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-2735-2024 (May 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2735-2024 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.