Beckman Coulter recalls Dxl 9000 Access Immunoassay Analyzers with software version 1.16.2 or older that may report inaccurate patient results due to expired calibration materials.
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Beckman Coulter is recalling Dxl 9000 Access Immunoassay Analyzers with software version 1.16.2 or older. These devices could report inaccurate patient test results if they use expired calibration materials, which might lead to incorrect medical decisions.
The device may process calibration orders using expired calibration materials. This can cause the instrument to generate patient results that are too high or too low, potentially leading to incorrect medical decisions.
Healthcare facilities using the Dxl 9000 Access Immunoassay Analyzer with software version 1.16.2 or older are most at risk. This includes labs and clinics that perform medical testing.
Check for U.S. serial numbers listed in the recall: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. The device also has software version 1.16.2 or older.
Verify the software version on your Dxl 9000 Access Immunoassay Analyzer. If it is 1.16.2 or older, it is affected.
Reach out to Beckman Coulter for guidance on next steps if your device is affected.
The device may process calibration orders using expired calibration materials, which can cause inaccurate patient test results.
Software version 1.16.2 or older.
Check for U.S. serial numbers listed in the recall: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0025-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0025-2025 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.
