Public recall detail

Liaison® Testosterone XT

2024-08-23

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Recall Safety notice
Quick summary

Quick summary: Liaison® Testosterone XT. Date: 2024-08-23.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Liaison® Testosterone XT. Date: 2024-08-23.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandDiasorin Inc.
ProductLiaison® Testosterone XT
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75961

Affected products

ProductLiaison® Testosterone XT
Lot136981
Model318410
Serial number136981
DescriptionLiaison® Testosterone XT

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

What you should do

  • Users instructed to stop using affected devices. Destroy remaining affected inventory.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Clinical toxicology
CompaniesDiasorin Inc. 1951 Northwestern Avenue, Stillwater, Minnesota, United States, 55082
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75961
Background{}
CompaniesDiasorin Inc. 1951 Northwestern Avenue, Stillwater, Minnesota, United States, 55082
AudiencesHealthcare
Source updated2024-08-23

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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