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Health Canada Medical devices

Liaison® Testosterone XT

Issued August 23, 2024
Issue
The affected kit lots of Liaison® Testosterone XT may produce falsely low results in samples below 2 ng/ml. Median values below 2 ng/ml show a negative bias to the median values listed in the IFU. The negative bias in samples below 2 ng/ml may impact interpretation of results relative to the reference range claims for the adult female populations and pediatric populations. Recall start date: July 29. 2024
Hazard description
Performance
Product
Product name
Liaison® Testosterone XT
Reference
ID
RA-75961