# Major Recall Alert: Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe Recalled Due to Increased Risk of False Negative Results in Hearing Tests
A critical recall has been issued for the **Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe**. The recall highlights an increased risk of **false negative results** during hearing screenings, particularly when the device is used with deviations from its factory default diagnostic protocol. If you or your healthcare organization rely on the **Madsen® AccuScreen®**, here's everything you need to know to protect your patients and ensure accurate testing.
## Why This Recall is Important
Hearing screenings are vital for early detection of auditory disorders in infants and children. Early intervention can significantly improve outcomes for children with hearing impairments, making accurate screening tools essential.
The **Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe**, manufactured for use in hearing assessments, has an **inherent risk of false pass results**, particularly for children with hearing disorders. While this risk cannot be entirely eliminated, it becomes significantly higher when users deviate from the **AccuScreen® factory default DPOAE Protocol (DP-1)** and use the device alongside the **DPOAE Probe 8-69-41100**.
False negatives can lead to missed diagnoses, thereby delaying essential intervention and impairing a child’s development. This recall ensures proper action is taken to mitigate risks and restore accuracy in hearing screenings.
## Details of the Recall
Here are the key facts about the **Madsen® AccuScreen® Probe recall**:
- **Category**: Medical Equipment – Canada
- **Brand Name**: **Madsen® AccuScreen®**
- **Product**: **TEOAE/DPOAE/ABR Probe**
- **Issue**: Increased risk of **false negative results** when deviating from the factory default DPOAE Diagnostic Protocols on the AccuScreen® system.
- **Affected Component**: Use of **DPOAE Probe 8-69-41100** in conjunction with altered protocols.
- **Safety Risk**: Delayed hearing disorder diagnosis in children due to inaccurate "pass" results.
- **Date Announced**: October 2023
- **Link to Official Recall Notice**: [Click here to view the official recall notice](https://recalls-rappels.canada.ca/en/alert-recall/madsenr-accuscreenr-teoaedpoaeabr-probe)
## What You Should Do
If you are a healthcare provider or organization using the Madsen® AccuScreen®, here are the steps to follow:
1. **Stop Using the Affected Product**
Immediately cease using the **DPOAE Probe 8-69-41100** with settings that deviate from the factory default **DPOAE Protocol (DP-1)**.
2. **Contact the Manufacturer**
Reach out to the equipment supplier or your local distributor for updates and guidance on managing this issue. Verify if your protocols align with the default DP-1 setting.
3. **Monitor Patient Outcomes**
Review results for any recent screenings completed using the affected device and protocols. If necessary, re-evaluate test results to ensure children have not been misdiagnosed.
4. **Notify Your Team**
Spread awareness within your organization to ensure no further misuse of the product occurs.
For further instructions, refer to the [official recall alert](https://recalls-rappels.canada.ca/en/alert-recall/madsenr-accuscreenr-teoaedpoaeabr-probe).
## Stay Safe – Get Instant Recall Alerts
Staying updated on recalls like this one is critical for patient safety. The **Madsen® AccuScreen® Probe recall** is a reminder of the importance of regularly reviewing diagnostic equipment and being aware of manufacturer updates.
**Download our free Recall Alert App today** to stay informed about the latest recalls and safety alerts. Whether you're in the healthcare field or a concerned parent, getting notifications in real-time can help protect your loved ones and the public.
### Take action now to safeguard your patients and ensure accurate hearing screenings.
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Accurate diagnostics are the foundation of effective healthcare, and ensuring the reliability of equipment is key. Stay proactive, informed, and safe with real-time updates on recalls such as this critical notice.