Beckman Coulter DxI 9000 Access Analyzer Recall: Wash Wheel Mixer Error Risk
Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with specific serial numbers due to potential wash wheel mixer malfunction causing test delays and system errors.
Use caution until it’s fixed
The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
Contact the company
What happened, in plain English
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers because their wash wheel mixer may not spin freely, which can cause tests to cancel and delay patient results. This issue affects laboratory equipment used for medical testing. Read more at govinfonow.com/recall/53500-beckman-coulter-dxi-9000-access-analyzer-recall-wash-wheel-mixer.
Source Summary by GovInfoNow · govinfonow.com/recall/53500-beckman-coulter-dxi-9000-access-analyzer-recall-wash-wheel-mixer · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1326-2025
Cite this page
“Beckman Coulter DxI 9000 Access Analyzer Recall: Wash Wheel Mixer Error Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53500-beckman-coulter-dxi-9000-access-analyzer-recall-wash-wheel-mixer. Based on FDA recall #Z-1326-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1326-2025%22&limit=1).
Why it’s dangerous
The wash wheel mixer may not spin freely within the idler pulley housing, causing the analyzer to generate a 'Wash Wheel Dispense Arm Spin Mixer Error' message. This can cancel ongoing tests and delay patient results without causing physical harm.
Who’s affected
Laboratories using the recalled DxI 9000 Access Immunoassay Analyzers with specific serial numbers are most at risk. Patients may experience delayed test results if the analyzer is in use.
How to tell if you have this one
Check for the catalog number C11137 and serial numbers listed in the recall notice (e.g., 300116, 300117, etc.). The device is used in laboratories for medical testing.
- Brand
Beckman Coulter- Category
Medical device
What to do — step by step
Check for Error Message
Look for a 'Wash Wheel Dispense Arm Spin Mixer Error' message on the analyzer's navigation bar.
Verify Serial Number
Confirm the device has a serial number from the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 4 months 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.
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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-1326-2025 (November 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1326-2025 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.