# Major Recall Alert: INNOVANCE® VWF Ac Assay Recalled Due to Falsely Elevated Results
Siemens Healthineers has issued a significant recall regarding the INNOVANCE® VWF Ac assay following a detailed investigation into customer complaints. Concerns have arisen over potential inaccuracies in both quality control and patient sample results, which may be falsely elevated, regardless of the system or reagent lot used. This recall is crucial for anyone using the product. Learn more about the details, why this recall is critical, and how to stay safe.
## Why This Recall is Important
Medical testing accuracy is essential for proper diagnosis and treatment. The INNOVANCE® VWF Ac assay, designed to assist in diagnosing von Willebrand disease—a condition affecting blood clotting—has shown potential for yielding falsely elevated results.
Such inaccuracies pose risks, including:
- **Inappropriate medical treatment**: Misdiagnosed patients may receive unnecessary or incorrect care.
- **Delayed proper diagnosis**: Physicians may rule out actual conditions due to skewed results.
- **Compromised trust in testing accuracy**: This issue impacts confidence in using the assay for monitoring patients.
Siemens Healthineers has acknowledged the potential for false-positive results even when quality control (QC) values appear within the permitted range. This critical flaw emphasizes the importance of addressing this recall promptly to prevent patient harm.
## Details of the Recall
Here’s what you need to know about the INNOVANCE® VWF Ac assay recall:
- **Brand**: INNOVANCE® VWF Ac assay
- **Product**: INNOVANCE® VWF Ac assay used for von Willebrand factor activity testing
- **Recall Date**: June 20, 2025
- **Reason for Recall**:
- Investigation confirmed patient sample results might be falsely elevated.
- QC test recovery issues were reported in control plasma P (CPP), with results exceeding permitted ranges.
- Elevated INNOVANCE® VWF Ac results could occur even when QC values fall within acceptable limits.
- **Location**: Canada
This recall aims to address these discrepancies to ensure accurate diagnostic results for patients and healthcare providers.
For the official recall notice, visit [SIEMENS Healthineers INNOVANCE® VWF Ac recall page](https://recalls-rappels.canada.ca/en/alert-recall/innovancer-vwf-ac-assay).
## What You Should Do
If you’re a healthcare provider or institution using the INNOVANCE® VWF Ac assay:
1. **Immediately stop using the affected assay.**
2. **Consult Siemens Healthineers** for further instructions and potential replacement measures.
3. **Review past patient results** to evaluate any potential discrepancies in diagnoses or treatments.
4. Monitor upcoming updates regarding the product to understand how and when the issue will be resolved.
For patients concerned about previous test results:
- **Contact your medical provider** to determine if retesting is necessary.
- Be vigilant for any changes in your condition or unusual symptoms.
## Stay Safe – Get Instant Recall Alerts
Product recalls like this emphasize the importance of staying informed about potential risks. Want to ensure you’re always aware of the latest recalls?
**Download our recall app today!**
- **Get real-time alerts on your phone.**
- **Access critical safety updates instantly.**
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Healthcare professionals and patients alike can benefit from proactive steps to ensure safety and accurate diagnosis. Protect yourself—download the app now and stay up-to-date on important product recalls.
For more details, always refer to official sources like the Government of Canada’s recall platform. Visit the INNOVANCE® VWF Ac assay [recall page here](https://recalls-rappels.canada.ca/en/alert-recall/innovancer-vwf-ac-assay).
Stay vigilant, ensure safety, and prioritize accurate healthcare with timely recall updates.