Cortisol Saliva Luminescence Immunoassay (2018-01-12)

Starting date:

January 12, 2018

Posting date:

February 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-65870

• 
  Reason
• 
  Affected products

Affected products

Cortisol Saliva Luminescence Immunoassay

Reason

IBL detected an issue that indicates degradation in performance of the kit that results in elevated cortisol values. When testing patient samples with one of the affected lots, the controls and calibrator values will meet specifications.

Affected products