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Liaison® Testosterone XT
Brand(s)
Summary
Users instructed to stop using affected devices. Destroy remaining affected inventory.
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
| Diasorin Inc. |
| 1951 Northwestern Avenue, Stillwater, Minnesota, United States, 55082 |
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