Salivary Progesterone HS 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 III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70191

Last updated: 2019-06-14

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  Reason
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  Affected products

Affected Products

Salivary Progesterone HS ELISA

Reason

The user of this assay may observe a higher percentage of samples with low results. Saliva samples in the low measuring range of the kit (less than 20 pg/mL) were assayed and producing a significantly lower result. Samples above 50 pg/mL were found to be accurate. This issue is caused by a component of the calibrator's matrix that has lost activity over time. It was found to be accurate.

Affected products