Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer C11137 with calibration issues that may cause incorrect test results and delays. Affected units have specific serial numbers.
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers due to calibration problems that can lead to incorrect test results. This means lab results might be misinterpreted as valid when they are not, potentially causing delays in diagnosis or treatment.
The analyzer may switch calibration status from passed to failed during sample aspiration due to system errors. This causes test results to be misinterpreted as valid when they are not, potentially leading to incorrect diagnoses or delayed treatment.
Lab users with the specific serial numbers listed in the recall notice are affected. Healthcare professionals and labs that use these analyzers for testing are most at risk.
Check if your DxI 9000 Access Immunoassay Analyzer has the serial numbers listed in the recall notice (e.g., 300116, 300124, etc.). The product model is C11137.
Verify your analyzer's serial number against the list of affected units provided in the recall notice.
The analyzer has calibration issues that can cause it to switch from passed to failed status during sample aspiration, leading to incorrect test results.
Check if your DxI 9000 Access Immunoassay Analyzer has a serial number listed in the provided recall notice (e.g., 300116, 300124, etc.).
The recall notice does not specify a remedy, so you should check with Beckman Coulter directly for further instructions.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1996-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1996-2025 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.
