Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers (REF C63520) due to software issues that may cause delayed results after processing 250 racks. Affected units have specific serial numbers.
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers with serial numbers starting with 2023070010 due to a software issue. After processing 250 racks, the analyzer may delay results for samples requiring rerun or reflex testing.
The software issue causes the analyzer to hold samples in the buffer area and report error code 9000 after processing 250 racks. This may delay results for samples that need to be rerun or refilled.
Healthcare facilities using the DxC 500 AU Clinical Chemistry Analyzer with specific serial numbers are affected. Laboratory staff and patients using this equipment for in vitro diagnostics are at risk of delayed test results.
Check if your DxC 500 AU Clinical Chemistry Analyzer has a serial number starting with 2023070010, 2023060005, or other listed numbers in the recall notice. The product is for in vitro diagnostic use only.
Verify your analyzer's serial number against the list of affected units provided in the recall notice.
The recall is due to a software issue that may cause delayed results after processing 250 racks, leading to error code 9000 for samples requiring rerun or reflex testing.
Check if your DxC 500 AU Clinical Chemistry Analyzer has a serial number starting with 2023070010, 2023060005, or other listed numbers in the recall notice.
The recall does not require immediate action beyond checking your serial number. No remedy is specified 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-2691-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2691-2024 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.
