Lower risk Medical device recall · FDA · Published March 5, 2024

Beckman Coulter DxI 9000 Analyzer Recall: Cracks Risk Leaks and Test Delays

Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with cracks in the wash buffer tank that may leak, causing test delays and exposure risks. Affected units have specific serial numbers.

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

🇺🇸 FDA recall #Z-1546-2024Medical device Beckman Coulter ›

Lower-risk recall

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

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 cracks in the wash buffer tank that can leak. This may cause delays in patient test results, exposure to hazards, and equipment damage. Affected units have specific serial numbers. Read more at govinfonow.com/recall/55989-beckman-coulter-dxi-9000-analyzer-recall-cracks-risk-leaks-and.

Source Summary by GovInfoNow · govinfonow.com/recall/55989-beckman-coulter-dxi-9000-analyzer-recall-cracks-risk-leaks-and · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1546-2024

Cite this page

“Beckman Coulter DxI 9000 Analyzer Recall: Cracks Risk Leaks and Test Delays.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55989-beckman-coulter-dxi-9000-analyzer-recall-cracks-risk-leaks-and. Based on FDA recall #Z-1546-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1546-2024%22&limit=1).

The FDA announced on March 5, 2024, that Beckman Coulter, Inc. is recalling DxI 9000 Access Immunoassay Analyzers due to manufacturing defects that can cause leaking. This leak may lead to delays in reporting patient test results and exposure to physical and chemical hazards.

How to tell if you have it

Brand: Beckman Coulter
Product: DxI 9000 Access Immunoassay Analyzer, REF C11137
Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282
Distribution: US Nationwide in New Hampshire; Belgium, Egypt, Italy, Poland, Spain

The hazard

Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank used within the Wash Buffer Supply Drawer. This defect can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Recent similar product recalls include the AU5800 Chemistry Analyzer Recall (Jan. 30, 2026) and the DxC 700 AU Recall (Jan. 30, 2026), both involving delays in results. Other recent recalls of similar products include the MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026) and the Access Total T4 Calibrator Recall (March 16, 2026).

How to tell if you have this one

Check for serial numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282. The device is a DxI 9000 Access Immunoassay Analyzer.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Cracks
Inspect the bottom of the Internal Wash Buffer Tank for cracks around the threaded insert.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.” 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 6 months after the firm started it.

Mar 5, 2024Firm started the recall
Aug 30, 2024FDA classified it Class II
Sep 11, 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/55989-beckman-coulter-dxi-9000-analyzer-recall-cracks-risk-leaks-and">Beckman Coulter DxI 9000 Analyzer Recall: Cracks Risk Leaks and Test Delays (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-1546-2024 (March 5, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1546-2024 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.