Official recall record

INNOVANCE® VWF Ac assay

Health Canada — Medical Devices · 2025-07-04 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-07-04
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: Health Canada — Medical Devices · Canada · all filters

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.