Use caution Medical device recall · FDA · Published July 10, 2024

Beckman Coulter DxI 9000 Access Analyzer Recall: Air Leaks Cause Sample Errors

Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with undersized pneumatic tubing that may cause air leaks and sample processing errors. Four complaints led to this recall.

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

🇺🇸 FDA recall #Z-3180-2024Medical device Beckman Coulter ›

Use caution until it’s fixed

Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatics Tubing in the reagent storage module causing air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.

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 certain DxI 9000 Access Immunoassay Analyzers due to undersized pneumatic tubing that can cause air leaks, compressor failures, or sample processing errors. This may delay test results and lead to inaccurate results. Read more at govinfonow.com/recall/54674-beckman-coulter-dxi-9000-access-analyzer-recall-air-leaks-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/54674-beckman-coulter-dxi-9000-access-analyzer-recall-air-leaks-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3180-2024

Cite this page

“Beckman Coulter DxI 9000 Access Analyzer Recall: Air Leaks Cause Sample Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54674-beckman-coulter-dxi-9000-access-analyzer-recall-air-leaks-cause. Based on FDA recall #Z-3180-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3180-2024%22&limit=1).

The FDA announced on July 10, 2024, that Beckman Coulter, Inc. is recalling its DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing causing air leaks and sample processing errors. Owners should contact the company for corrective action.

How to tell if you have it

Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer
Model Number: C21510
Kit: RSM Pneumatic Tubing Kit item #2, REF C11137
Serial Numbers: 300116 through 300333 (specific list in record)
Quantity: 170 units

The hazard

The recall addresses undersized Pneumatics Tubing in the reagent storage module which can cause air leaks, compressor failures or sample processing errors. Four complaints were filed for this event that led to Beckman Coulter finding undersized tubing in stock and initiated corrective actions. Use of the affected device may result in errors leading to delay of results.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since 2017-06-20. Other recent recalls of similar products include Beckman Coulter DxC 500 AU Modules with Software 1.5 Risk Patient Test Errors (2026-07-15), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11: Incorrect Algorithms May Affect Test Results (2026-06-26), and Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (2026-03-16). Additional similar recalls include Beckman Coulter Bicarbonate Reagent May Cause False High Results - Recall (2025-10-14), Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (2026-01-30), and Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (2026-01-30).

How to tell if you have this one

Check for the model number C21510 and the specific serial numbers listed in the recall notice. The affected units were sold with the RSM Pneumatic Tubing Kit item #2.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Air Leaks
Inspect the reagent storage module for signs of air leaks or unusual noises that might indicate compressor issues.
Contact Manufacturer
Reach out to Beckman Coulter for guidance on corrective actions or potential replacements for the affected units.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal,…” 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 3 months after the firm started it.

Jul 10, 2024Firm started the recall
Sep 19, 2024FDA classified it Class II
Sep 25, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/54674-beckman-coulter-dxi-9000-access-analyzer-recall-air-leaks-cause">Beckman Coulter DxI 9000 Access Analyzer Recall: Air Leaks Cause Sample Errors (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-3180-2024 (July 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3180-2024 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.