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Health product recall

Liaison® Testosterone XT

Brand(s)
Last updated

Summary

Product
Liaison® Testosterone XT
Issue
Medical devices - Performance
What to do

Users instructed to stop using affected devices. Destroy remaining affected inventory.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Liaison® Testosterone XT 136981 318410

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Clinical toxicology
Companies
Diasorin Inc.
1951 Northwestern Avenue, Stillwater, Minnesota, United States, 55082
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75961

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