Beckman Coulter recalls DxC 500i Clinical Analyzer Modules due to software issue causing false patient results if samples are retested with same ID number.
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 DxC 500i Clinical Analyzer Modules that may produce false low or high patient results when retesting samples with the same ID number. This could lead to incorrect diagnoses if undetected.
The software anomaly prevents correct application of manual dilution factors when retesting samples already marked as 'In Progress' with the same Sample ID number. This can cause false low or high patient results, potentially leading to delayed diagnoses if the error goes unnoticed.
Healthcare facilities using DxC 500i Clinical Analyzer Modules with specific serial numbers or part numbers listed in the recall. Laboratory staff and patients who receive tests using these modules are at risk of incorrect results.
Check if your DxC 500i Clinical Analyzer Modules have the part numbers C63522, C63521, or C13252, or the listed serial numbers. The recall includes specific models and part numbers from the provided list.
Verify if your DxC 500i Clinical Analyzer Module has the part numbers C63522, C63521, or C13252, or the listed serial numbers.
Beckman Coulter identified a software anomaly that may prevent correct application of manual dilution factors when retesting samples already marked as 'In Progress' with the same Sample ID number.
This could lead to false low or high patient results, potentially causing delayed diagnoses if the error goes undetected.
Check if your module has the specific part numbers or serial numbers listed in the recall. No immediate action is required beyond verification.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0215-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0215-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
