Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific software versions that may show expired assays as valid, risking inaccurate patient test results. Affected units must be checked for software versions.
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers with certain software versions that may display expired assay dates as valid. This could lead to inaccurate patient test results if users continue using these analyzers without updating the software.
The software issue causes the analyzer to show incorrect expiration dates for assays loaded before a software upgrade. This means expired assays might still be used, potentially leading to inaccurate or erroneous patient test results. The problem only affects assays loaded before the upgrade and not new installations.
Healthcare facilities using Beckman Coulter DxC 500 AU analyzers with software versions V1.4 through V1.4.3 are most at risk. Patients receiving tests from these analyzers could get inaccurate results if expired assays are processed.
Check your DxC 500 AU analyzer's software version. Affected units have software versions V1.4 through V1.4.3. The recall includes specific reference numbers (C63519 and C63520) with associated serial numbers and dates.
Look for the software version on your DxC 500 AU analyzer. Affected units have versions V1.4 through V1.4.3.
Contact Beckman Coulter to update the software to a version after V1.4.3 to fix the issue.
No, you can continue using it as long as you update the software to a version after V1.4.3 to fix the issue.
Software versions V1.4 through V1.4.3 are affected. New installations are not impacted.
Check your software version. Affected units have specific reference numbers (C63519 and C63520) with serial numbers listed in the recall notice.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1233-2025 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.
