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Health Canada Medical devices

cobas® pro and cobas® pure

Issued February 4, 2026
Issue
A rare software malfunction has been identified on the cobas® pro (c503) and cobas® pure (c303) platforms affecting the calibration library. This defect only occurs with cobas® pro software version <03-01 or cobas® pure software version <01-04. It can impact assays using spline-type calibration.
Hazard description
Performance
Product
Product name
cobas® pro and cobas® pure
Reference
ID
RA-81568