Madsen® AccuScreen® Hearing Screening Probe Recalled Due to Risk of False Negative Results
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, MedicalDevice.
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 ↗
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