Lower risk Medical device recall · FDA · Published April 18, 2024

Beckman Coulter Dxl 9000 Access Immunoassay Analyzer Recall: Expired Calibration Risk

Beckman Coulter recalls Dxl 9000 Access Immunoassay Analyzers with software version 1.16.2 or older that may report inaccurate patient results due to expired calibration materials.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0025-2025Medical device Beckman Coulter ›

Lower-risk recall

When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.

Take action

Contact the company

Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling Dxl 9000 Access Immunoassay Analyzers with software version 1.16.2 or older. These devices could report inaccurate patient test results if they use expired calibration materials, which might lead to incorrect medical decisions. Read more at govinfonow.com/recall/55352-beckman-coulter-dxl-9000-access-immunoassay-analyzer-recall-expired-calibration.

Source Summary by GovInfoNow · govinfonow.com/recall/55352-beckman-coulter-dxl-9000-access-immunoassay-analyzer-recall-expired-calibration · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0025-2025

Cite this page

“Beckman Coulter Dxl 9000 Access Immunoassay Analyzer Recall: Expired Calibration Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55352-beckman-coulter-dxl-9000-access-immunoassay-analyzer-recall-expired-calibration. Based on FDA recall #Z-0025-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0025-2025%22&limit=1).

Beckman Coulter, Inc. voluntarily recalled its DxI 9000 Access Immunoassay Analyzer on April 18, 2024, according to the FDA. The device may process orders with expired calibrator material, potentially leading to erroneous patient results.

How to tell if you have it

Beckman Coulter Dxl 9000 Access Immunoassay Analyzer
REF #C11137
UDI-DI: 15099590230623
System software version 1.16.2 and prior
U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234

The hazard

When configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to physicians.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls include the Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (July 15, 2026), the Beckman Coulter MicroScan LabPro V5.03 Panel Update 11: Incorrect Algorithms May Affect Test Results (June 26, 2026), and the Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026). Other recent recalls of similar products include the Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results (Jan. 30, 2026), the Beckman Coulter Emit 2000 Quinidine Assay Recall: Risk of Incorrect Patient Treatment (July 13, 2026), and the Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (Jan. 30, 2026).

How to tell if you have this one

Check for U.S. serial numbers listed in the recall: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. The device also has software version 1.16.2 or older.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Dxl 9000 Access Immunoassay Analyzer. If it is 1.16.2 or older, it is affected.
Contact Manufacturer
Reach out to Beckman Coulter for guidance on next steps if your device is affected.

Where it went and when

Where it was distributed

Distributed in 9 states, and outside the U.S.

FDA distribution: “Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Georgia, Indiana, Kansas, New Hampshire, New Jersey, Oklahoma, Pennsylvania, Texas.

Recall timeline

FDA published this recall 6 months after the firm started it.

Apr 18, 2024Firm started the recall
Oct 7, 2024FDA classified it Class II
Oct 16, 2024Published 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

More Beckman Coulter recalls

Link to this recall

<a href="https://govinfonow.com/recall/55352-beckman-coulter-dxl-9000-access-immunoassay-analyzer-recall-expired-calibration">Beckman Coulter Dxl 9000 Access Immunoassay Analyzer Recall: Expired Calibration Risk (GovInfoNow)</a>

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-0025-2025 (April 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0025-2025 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.