17 Alpha-HydroxyProgesterone ELISA Kit (2018-05-04)

Starting date:

May 4, 2018

Posting date:

June 1, 2018

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-66924

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  Reason
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  Affected products

Affected products

17 Alpha-HydroxyProgesterone (17α-OHP) ELISA Kit

Reason

This recall has been initiated due to the fact that the standards and kit controls could degrade, resulting in an invalid standard curve and out of range kit control values. This would lead to an inability to meet the QC certificate acceptance criteria and result in an invalid test.

Affected products