Recall Monitor
Health Products

INNOVANCE® VWF Ac assay

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Haematology
Product: INNOVANCE® VWF Ac assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
INNOVANCE® VWF Ac assayAll lots.10873906
INNOVANCE® VWF Ac assayAll lots.10487040

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

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