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Health Canada Medical devices

DxC 500 AU Clinical Chemistry Analyzer

Issued March 6, 2025
Issue
Beckman Coulter has determined that the system cannot recalculate a calculated result when results are rerun within the calculated test. The system will report only the calculated result using the initial constituent tests' results to the operator and lis/middleware. A patient may receive unnecessary treatment or testing; or patient treatment may be delayed. Recall Start Date: February 13, 2025
Hazard description
Performance
Product
Product name
DxC 500 AU Clinical Chemistry Analyzer
Reference
ID
RA-77067