Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer with software error causing intermittent hard stops and delayed patient results. Affected units have specific serial numbers.
A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Beckman Coulter is recalling its DxI 9000 Access Immunoassay Analyzer due to a software error that causes intermittent hard stops and delays in patient results. This could lead to inaccurate test results if the device stops unexpectedly during use.
A software error increases tray gripper motion errors, causing the device to stop unexpectedly and delay patient results. This could lead to inaccurate test outcomes if the device stops during critical testing procedures.
Healthcare facilities using the Beckman Coulter DxI 9000 Access Immunoassay Analyzer with specific serial numbers are most at risk. Laboratory staff and patients using this device for in-vitro diagnostics may be affected.
Check if your device has the catalog number C11137 and the listed serial numbers (e.g., 300208, 300201, etc.). The product is an in-vitro diagnostic instrument sold for medical testing.
Verify if your device has the catalog number C11137 and one of the listed serial numbers.
The software error increases tray gripper motion errors, causing intermittent hard stops and delays in patient results.
Check if your device has the catalog number C11137 and one of the listed serial numbers (e.g., 300208, 300201, etc.).
No immediate stop is required, but you should check if your device is affected and verify the status.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1115-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1115-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
