Beckman Coulter DxI 9000 Analyzer C11137: Calibration Errors Cause Wrong Results
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer C11137 with calibration issues that may cause incorrect test results and delays. Affected units have specific serial numbers.
Lower-risk recall
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
Contact the company
What happened, in plain English
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to calibration problems that can lead to incorrect test results. This means lab results might be misinterpreted as valid when they are not, potentially causing delays in diagnosis or treatment. Read more at govinfonow.com/recall/52335-beckman-coulter-dxi-9000-analyzer-c11137-calibration-errors-cause-wrong.
Source Summary by GovInfoNow · govinfonow.com/recall/52335-beckman-coulter-dxi-9000-analyzer-c11137-calibration-errors-cause-wrong · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1996-2025
Cite this page
“Beckman Coulter DxI 9000 Analyzer C11137: Calibration Errors Cause Wrong Results.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52335-beckman-coulter-dxi-9000-analyzer-c11137-calibration-errors-cause-wrong. Based on FDA recall #Z-1996-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1996-2025%22&limit=1).
Why it’s dangerous
The analyzer may switch calibration status from passed to failed during sample aspiration due to system errors. This causes test results to be misinterpreted as valid when they are not, potentially leading to incorrect diagnoses or delayed treatment.
Who’s affected
Lab users with the specific serial numbers listed in the recall notice are affected. Healthcare professionals and labs that use these analyzers for testing are most at risk.
How to tell if you have this one
Check if your DxI 9000 Access Immunoassay Analyzer has the serial numbers listed in the recall notice (e.g., 300116, 300124, etc.). The product model is C11137.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check Serial Numbers
Verify your analyzer's serial number against the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 24 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI, ID, IL, IN, KY, LA, ME, MI, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, WA, WI and the countries of Algeria, Australia, Austria, Belgium, Brazil, C¿te d'Ivoire,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Michigan, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 56 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.
Similar recalls
Latest medical device recalls
Keep exploring
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-1996-2025 (May 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1996-2025 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.