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Health Canada Medical devices

INNOVANCE® VWF Ac assay

Issued July 4, 2025
Issue
Siemens Healthineers has confirmed through the investigation of customer complaints that quality control and patient sample results for INNOVANCE® VWF Ac might be falsely elevated, independent of the system and reagent lot used. An increased number of complaints for the test INNOVANCE® VWF Ac were received, where customers complained of quality control (qc) recovery issues for control plasma p (cpp). Results were found above the permitted range according to the table of assigned values. There is a potential of elevated INNOVANCE® VWF Ac patient results where qc is within the permitted range. Date de début du rappel: le 20 juin 2025
Hazard description
Performance
Product
Product name
INNOVANCE® VWF Ac assay
Reference
ID
RA-77670