Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with software bugs that could cause incorrect patient test results. No immediate action is needed but users should check for specific serial numbers.
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers due to two software issues that might cause incorrect patient test results. The risk of serious injury or death is unlikely, but the errors could lead to wrong medical decisions.
The analyzer has two software bugs: one allows calibration racks to be reused for patient and calibration orders, potentially mixing results. The other involves using expired calibrators, which can cause inaccurate test outcomes. Both issues could lead to wrong patient results but do not typically cause serious injury or death.
Healthcare facilities using the DxC 500 AU Clinical Chemistry Analyzer with serial numbers listed in the recall are affected. Laboratory staff and patients who rely on this device for testing are at risk of incorrect results.
Check if your DxC 500 AU Clinical Chemistry Analyzer has a serial number listed in the provided range (e.g., 2023070010, 2023060005). The device is for in vitro diagnostic use only and requires specific calibration procedures.
Verify if your analyzer has a serial number from the list provided in the recall (e.g., 2023070010, 2023060005).
The recall states that the probability of serious adverse health consequences or death is unlikely, but incorrect test results could lead to wrong medical decisions.
Check if your analyzer has a serial number from the list provided in the recall. If it does, you may need to contact Beckman Coulter for further instructions.
The recall does not specify a remedy, so no immediate action is needed beyond checking your serial number.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2455-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2455-2024 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.
