INNOVANCE® VWF Ac assay

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