Health product recall

Surestrips Rapid Response Covid-19 Antigen Rapid Test Device

Last updated

Summary

Product
Surestrips Rapid Response Covid-19 Antigen Rapid Test Device
Issue
Medical devices - Unauthorised device
COVID
What to do

Contact supplier for the disposal or exchange of the product.

Affected products

Affected products Lot or Serial number Model or Catalogue number
Surestrips Rapid Response Covid-19 Antigen Rapid Test Device 21100012 21100017 11157919 21120017 11157782 21120012 21120015 21120010 COV-19C25

Issue

Surestrips Rapid Response Covid-19 Antigen Rapid Test Device are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e. BTNX Inc.). 

Recall start date: April 11, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

All Clean Natural Ltd.

5310 1st Street Sw, Calgary, Alberta, Canada, T2H 0C8

Published by
Health Canada
Audience
General public
Healthcare
Hospitals
Recall class
Type II
Identification number
RA-64213