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Health Canada Medical devices

Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay

Issued October 17, 2025
Issue
Customer complaints were received for multiple bicarbonate reagent lots associated with false high patient results for bicarbonate. The high results are due to elevated levels of LDH in the patient samples tested. The current bicarbonate product IFU's do not advise of LDH interference with this assay.
Hazard description
Performance
Product
Product name
Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay
Reference
ID
RA-78310