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Health Canada Medical devices

Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay

Issued April 13, 2023
Issue
Beckman Coulter has confirmed a premature decrease in calibration ODs for several lots of bicarbonate OSR6X37. It is possible that all bicarbonate lots may also be impacted by this issue, therefore all lots are subject to this field action. The abnormal decrease in calibrator ODs may result in calibration failures and/or OC failures. the risk of generating falsely elevated, clinically impactful patient test results is remote. Recall start date: April 3, 2023
Hazard description
Performance
Product
Product name
Beckman Coulter Au Immunochemistry System - Bicarbonate (CO2) Assay
Reference
ID
RA-73500