Beckman Coulter DxC 500 AU Chemistry Analyzer Software Calibration Error
Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer due to a software error that prevents the analyzer from completing calibration orders under certain conditions, which can delay test result reporting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text explicitly states no illnesses or injuries have been reported, and the hazard is operational dysfunction (delayed test reporting) rather than direct patient harm. The error causes service delays but not immediate clinical consequences.
Plain-English summary
Beckman Coulter Inc. is recalling the DxC 500 AU Clinical Chemistry Analyzer (Catalog Numbers C63519 and C63520) due to a software error. The analyzer fails to complete calibration orders when a reagent blank or calibration is ordered during sample processing and any reagent component (R1 and/or R2) depletes to zero tests. When this occurs, the calibration order remains pending and no further calibration orders can be processed for any assays.
As a result of this error, the analyzer refuses to accept further sample processing orders once existing calibration curves expire. Although in-process tests will be completed, this error can cause delays in reporting subsequent test results. The affected analyzers are distributed in the United States (AL, CA, GA, ID, IN, LA, MA, MI, MN, MT, NC, NV, PA, PR, TN, TX, and WI) and internationally (Australia, Belgium, Bosnia and Herzegovina, Canada, Chile, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Puerto Rico, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, and Tunisia).
Customers using affected analyzers should contact Beckman Coulter Inc. for guidance on this software issue.
The recalled product
- Product
- DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with…
- Manufacturer
- Beckman Coulter Inc.
Distribution
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