Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer with software version 1.20 due to error codes preventing assay results. Affected units may require field service.
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers with software version 1.20 because this update causes error codes that prevent proper testing and delay results. Users should check if their device has the affected software version.
The software update v1.20 introduces error codes that prevent the device from performing tests correctly and delays result generation. This may require field service to fix the delay, but does not cause immediate injury or damage.
Users of the DxI 9000 Access Immunoassay Analyzer with software version 1.20 (specifically catalog number C11137) are affected. Laboratory personnel who use this device for medical testing are most at risk.
Check if your DxI 9000 Access Immunoassay Analyzer has catalog number C11137 and software version 1.20. Serial numbers listed in the recall include many numbers starting with 300000.
Verify your device's software version; affected units run version 1.20.
The software update v1.20 introduces error codes that prevent the assay from being performed and delays result generation, requiring field service to resolve.
No, the recall does not require stopping use; affected units may continue operating but require field service for the delay issue.
Check for catalog number C11137 and software version 1.20; serial numbers listed in the recall include many starting with 300000.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1913-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1913-2025 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.
