SARS-COV-2 RAPID ANTIGEN TEST NASAL WITH CONTROL
Brand(s)
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
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