Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer with software anomaly that may cause false low/high patient results if manual dilution factors aren't applied correctly. Affected units have specific serial numbers.
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to a software issue that can cause false low or high patient test results when ordering additional tests for samples already in progress. This could lead to incorrect diagnoses if undetected.
The software anomaly may prevent the device from correctly applying user-specified manual dilution factors when ordering additional tests for samples already marked as "In Progress" using the same Sample ID number. This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
Healthcare facilities using the DxI 9000 Access Immunoassay Analyzer with specific serial numbers are most at risk. The issue affects the software's ability to apply manual dilution factors correctly.
Check if your DxI 9000 Access Immunoassay Analyzer has the part number C11137 and one of the listed serial numbers (many are provided in the recall notice).
Verify your device's serial number against the list of affected units provided in the recall notice.
The recall describes a software issue that could cause false low or high patient results if manual dilution factors aren't applied correctly. If you've been using the device as described, there may be a risk of incorrect results.
Check your device's serial number against the list of affected units provided in the recall notice. The affected units have part number C11137 and specific serial numbers listed in the recall.
The recall does not specify a remedy, so the official notice does not provide instructions for affected devices.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0216-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0216-2026 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.
