Beckman Coulter recalls DxC 500 AU Module with ISE and without ISE for potential processing delays when ordering clinical chemistry and immunoassay tests together. Affected units may show incorrect status during testing.
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
Beckman Coulter is recalling DxC 500 AU Modules with and without ISE to prevent processing delays when clinical chemistry and immunoassay tests are ordered together. This could cause tests to remain in progress without errors, potentially delaying results.
When a clinical chemistry test is ordered with an immunoassay test, the system may show the clinical chemistry sample as 'In Progress' without errors. This can cause delays in test results if the immunoassay test is processed between the clinical chemistry tests.
Laboratories using Beckman Coulter DxC 500i Clinical Analyzers with the recalled modules are most at risk. The issue affects specific software versions and module references.
Check for module references C63522 or C63521 on the DxC 500 AU Module. The software version is either 1.3.3 or 1.3.4. These modules are part of the DxC 500i Clinical Analyzer.
Look for module reference numbers C63522 or C63521 on the DxC 500 AU Module.
The recall is to prevent processing delays when clinical chemistry and immunoassay tests are ordered together. The system may show clinical chemistry samples as 'In Progress' without errors, causing delays.
Software versions 1.3.3 and 1.3.4 are affected.
Check for module reference numbers C63522 or C63521 on the DxC 500 AU Module. These modules are part of the DxC 500i Clinical Analyzer.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0032-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0032-2026 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.
