Madsen® AccuScreen® Hearing Screening Probe Recalled Due to Risk of False Negative Results
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 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.
Source: Health Canada Official Notice