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Innovance® vwf ac assay

Official notice

4 Jul 2025

MediumHealth Canada

An official Health Canada notice concerns 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 Published 2025-07-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77670

Official notice

2025-07-04

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77670

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Affected products

Product 1

Affected products - INNOVANCE® VWF Ac assay, Lot or serial number - All lots., Model or catalog number - 10873906

Product 2

Affected products - INNOVANCE® VWF Ac assay, Lot or serial number - All lots., Model or catalog number - 10487040

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Innovance® Vwf AC Assay.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77670

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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