Salivary Testosterone ELISA (2019-05-20)

Starting date:

May 20, 2019

Posting date:

June 14, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70197

Last updated: 2019-06-14

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  Reason
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  Affected products

Affected Products

Salivary Testosterone ELISA

Reason

The user of this assay may determine higher percentage of samples with 0 pg/mL testosterone or too low results. Saliva samples in the low measuring range of the kit (less than 50 pg/ml) were assayed significantly lower. Samples between 50 and 150 pg/mL were found approx. 30 % lower. Therefore there is a possibility of inappropriate diagnosis.

Affected products