Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers with software version 1.15 or older that may show wrong test results due to barcode errors when connected to lab systems.
The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers with software version 1.15 or older. These devices may show wrong test results when connected to laboratory information systems because a sample barcode can be replaced with an older sample ID.
When the device connects to a laboratory information system, it may ignore the sample barcode and use an older sample ID from the same rack. This can cause the device to show the results of the wrong sample (Sample B) as the results for a previous sample (Sample A).
Lab technicians and healthcare facilities using the DxI 9000 Access Immunoassay Analyzer with software version 1.15 or older may be affected. Those handling blood samples for diagnostic testing are most at risk.
Check if your DxI 9000 Access Immunoassay Analyzer has software version 1.15 or older. The device is sold as an in vitro diagnostic product with UDI/DI 15099590732103.
Verify your device's software version; if it is 1.15 or older, it is affected.
The device may show wrong test results when connected to laboratory information systems due to barcode errors.
Check if your DxI 9000 Access Immunoassay Analyzer has software version 1.15 or older.
The official recall notice does not specify a remedy or action 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-0107-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0107-2024 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.
