Beckman Coulter DxI 9000 Access Analyzer Software Update Causes Errors - Recall
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer with software version 1.20 due to error codes preventing assay results. Affected units may require field service.
Lower-risk recall
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Contact the company
What happened, in plain English
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers with software version 1.20 because this update causes error codes that prevent proper testing and delay results. Users should check if their device has the affected software version. Read more at govinfonow.com/recall/52423-beckman-coulter-dxi-9000-access-analyzer-software-update-causes-errors.
Source Summary by GovInfoNow · govinfonow.com/recall/52423-beckman-coulter-dxi-9000-access-analyzer-software-update-causes-errors · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1913-2025
Cite this page
“Beckman Coulter DxI 9000 Access Analyzer Software Update Causes Errors - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52423-beckman-coulter-dxi-9000-access-analyzer-software-update-causes-errors. Based on FDA recall #Z-1913-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1913-2025%22&limit=1).
Why it’s dangerous
The software update v1.20 introduces error codes that prevent the device from performing tests correctly and delays result generation. This may require field service to fix the delay, but does not cause immediate injury or damage.
Who’s affected
Users of the DxI 9000 Access Immunoassay Analyzer with software version 1.20 (specifically catalog number C11137) are affected. Laboratory personnel who use this device for medical testing are most at risk.
How to tell if you have this one
Check if your DxI 9000 Access Immunoassay Analyzer has catalog number C11137 and software version 1.20. Serial numbers listed in the recall include many numbers starting with 300000.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check Software Version
Verify your device's software version; affected units run version 1.20.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using my device?
No, the recall does not require stopping use; affected units may continue operating but require field service for the delay issue.
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Where this comes from
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-1913-2025 (April 23, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1913-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.