Clinical Chemistry Analyzer Software Issue Causes Delayed Results
Beckman Coulter clinical chemistry analyzers have a software issue that delays diagnostic results after processing 250 racks. Affected units experience buffer errors and result delays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a software issue causing operational delays and result delays without any reported illnesses or injuries, fitting the 'Moderate' severity category.
Plain-English summary
Beckman Coulter Mishima K.K. is recalling 24 units of the DxC 500 AU Clinical Chemistry Analyzer, a medical device used in clinical laboratories to measure analytes in patient samples. The recalled units are identified by catalog number C63520 and specific serial numbers ranging from 2023 to 2024.
A software issue affects these analyzers: after processing 250 racks cumulatively, any subsequent racks requiring rerun or reflex testing will be held in the Sample Handler's buffer area, and an error code 9000 will be reported. This causes a delay in diagnostic results.
The affected analyzers were distributed nationwide to clinical laboratories in Alabama, California, Georgia, Hawaii, Illinois, Michigan, Minnesota, Mississippi, Nebraska, New York, Oregon, Pennsylvania, and South Carolina, as well as to facilities in Lebanon and South Africa. Users should contact Beckman Coulter for instructions on device firmware updates or other corrective actions.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
- Manufacturer
- Beckman Coulter Mishima K.K.
- Hazard
- software-malfunction
- delayed-results
Distribution
Distributed nationwide across the United States.
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