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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