Madsen® AccuScreen® Hearing Screening Probe Recalled Due to Risk of False Negative Results

Source: Health Canada · Canada

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Natus Medical Denmark Aps has recalled the Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe due to an increased risk of false pass results in hearing screenings for children.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on March 4, 2026 and geographically references Canada. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Product & Food Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly Health Canada detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized Health Canada recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Natus Medical Denmark Aps has issued a health product recall for the Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe. The recall was initiated because of an increased risk of "false pass" (false negative) results during DPOAE testing protocols. While an inherent risk of false passes exists for children with hearing disorders, this risk is significantly heightened when the AccuScreen® factory default DPOAE Protocol (DP-1) is not followed while using the specific probe model 8-69-41100.

Which Products Are Affected

The recall affects the following medical device:

  • Product Name: Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
  • Model/Catalogue Number: 8-69-41100
  • Serial Numbers: More than 10 serial numbers are affected. Consumers are advised to contact the manufacturer for specific identification.

What You Should Do

Healthcare providers and facilities using these probes should contact Natus Medical Denmark Aps for further information regarding the affected units. It is critical to ensure that the AccuScreen® factory default DPOAE Protocol (DP-1) is utilized to minimize the risk of inaccurate test results.

Why This Matters

An undetected hearing disorder due to a false negative screening result can delay essential diagnosis and treatment for a child, potentially impacting their long-term development.

Source

Information provided by Health Canada.

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Natus Medical Denmark Aps has recalled the Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe due to an increased risk of false pass results in hearing screenings for children.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.