Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software version 1.16 or older that may produce incorrect test results, potentially affecting insulin measurements and lab reporting.
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or < ) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.
Beckman Coulter is recalling DxI 9000 Access Immunoassay Analyzers running software version 1.16 or older. These devices could produce incorrect test results for insulin and other analytes, which might lead to wrong lab reports or delayed results.
The software issues can cause incorrect insulin unit conversions, numerical results below the lowest reportable value, and improper reporting of results with special symbols. These problems may lead to wrong lab results or delays in reporting for multiple tests.
Laboratories using the DxI 9000 Access Immunoassay Analyzer with software version 1.16 or older are affected. Lab staff who run tests on these devices are most at risk of incorrect results.
Check if your DxI 9000 Access Immunoassay Analyzer has software version 1.16 or older. The serial numbers listed in the recall include 300116 through 300264.
Contact Beckman Coulter to update the software to version 1.17 or later to fix the issues.
No, the recall does not require immediate stoppage. Updating the software resolves the issues.
Software version 1.16 or older is affected.
Check the serial numbers listed in the recall (300116 through 300264) or contact Beckman Coulter for 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-0982-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0982-2024 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.
