Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers due to a software error that prevents calibration orders from completing, potentially delaying test results.
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers because a software error can cause calibration orders to remain pending, delaying test results. This affects labs using the equipment for in vitro diagnostics.
A software error prevents the analyzer from completing calibration orders when reagent components deplete to zero. This causes pending calibration requests and halts new sample processing after calibration curves expire, delaying test results without causing physical harm.
Labs and healthcare facilities using Beckman Coulter DxC 500 AU Clinical Chemistry Analyzers with catalog numbers C63519 or C63520 are most at risk. The issue primarily impacts test reporting timelines rather than immediate safety.
Check for catalog numbers C63519 or C63520 on the analyzer. The UDI codes 14987666545058 and 14987666545065 are also associated with these models.
Review the analyzer's calibration status to identify pending orders that may need resolution.
No, the recall does not pose a direct safety risk but may cause delays in test reporting.
Check for catalog numbers C63519 or C63520 on the analyzer, or UDI codes 14987666545058 and 14987666545065.
The official recall does not specify a remedy, so contact Beckman Coulter directly for 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-1784-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1784-2025 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.
