Health product recall

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

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

Cortisol Saliva Luminescence Immunoassay

Lot or serial number
  • LCL 130
  • LCL 134
Model or catalog number
  • RE62111
  • RE62119
Companies
Manufacturer
IBL International GmbH
Flughafenstrasse 52A
Hamburg
22335
GERMANY