Health product recall

SARS-COV-2 RAPID ANTIGEN TEST NASAL WITH CONTROL

Last updated

Summary

Product
SARS-COV-2 RAPID ANTIGEN TEST NASAL WITH CONTROL
Issue
Medical devices - Unauthorised device
COVID
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
SARS-COV-2 RAPID ANTIGEN TEST NASAL WITH CONTROL 381133II-2 381134II-1 381135II-2 381136II-1 381136II-3 381138II-1 381139II-1 381142II-1 9901-NCOV-03G

Issue

The manufacturer confirmed that some SARS-COV-2  Rapid Antigen Test Nasal kits lots were erroneously distributed with Medico swabs, which are not included in the current Health Canada interim order authorization for that kit.

Recall start date: 2021-11-11

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies

Importer: ROCHE DIAGNOSTICS

201, BOUL. ARMAND-FRAPPIER, LAVAL

QC, CANADA

H7V 4A2

 

Manufacturer: SD BIOSENSOR, INC

16, DEOGYEONG-DAERO, 1556BEON-GIL, YEONGTONG-GU, C-4 & 5 FLOOR,

SUWON-SI, GD, SOUTH KOREA

16690

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63653