Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer (Catalog Numbers C63519 and C63520) because a software error can prevent required calibrations from finishing. This issue occurs when a reagent runs out while the system is processing samples and a calibration is pending. While tests already being processed will finish, the instrument will stop processing new samples and calibrations once existing calibration curves expire, which can cause significant delays in medical test results.
The software calibration error prevents the analyzer from accepting new test orders, leading to delays in reporting diagnostic results to medical professionals. No injuries or incidents have been reported, but diagnostic delays can impact patient care.
Recall #: Z-1784-2025. Automated chemistry analyzer for in vitro diagnostic use.
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Sources: FDA iRES · Raw API Response
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