Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific software versions due to a defect that may cause delays in reporting patient test results when recalculating results.
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Beckman Coulter is recalling certain DxC 500 AU Clinical Chemistry Analyzers that have software versions V1.3 through V1.4.3. This defect can cause delays in reporting patient results when the system recalculates test results after rerunning constituent tests.
The software defect causes the analyzer to report only the initial calculated results instead of recalculating using rerun test results. This happens when the system automatically or manually reruns constituent tests, potentially leading to delayed patient result reporting.
Healthcare facilities using the DxC 500 AU Clinical Chemistry Analyzer with specific catalog numbers and serial numbers listed in the recall notice are affected. Laboratory staff and patients who rely on this equipment for in vitro diagnostic testing are at risk of delayed results.
Check for catalog numbers C63519 or C63520 with UDI codes 14987666545058 or 14987666545065. The device is identified by specific serial numbers listed in the recall notice.
Verify the software version on your DxC 500 AU Clinical Chemistry Analyzer to ensure it is not V1.3, V1.4, V1.4.1, V1.4.2, or V1.4.3.
Beckman Coulter identified a software defect that causes the analyzer to report only initial calculated results instead of recalculating when constituent tests are rerun, potentially delaying patient results.
Check for catalog numbers C63519 or C63520 with UDI codes 14987666545058 or 14987666545065, and verify the serial numbers listed in the recall notice.
The recall does not include a specific remedy; you should check the software version and contact Beckman Coulter for further guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1517-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1517-2025 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.
