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Rapid Response 1-Step DOA Test
- Starting date:
- November 4, 2016
- Posting date:
- December 5, 2016
- 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-61278
Reason
Non-compliance of the labeling information on the outer container. The outer container from this particular Lot (D607082) did not contain the device identifier.
Affected products
Rapid Response 1-Step DOA Test
Lot or serial number
D607082
Model or catalog number
D1W-11
Companies
- Manufacturer
-
BTNX Inc.
23-570 Hood Road
Markham
L3R 4G7
Ontario
CANADA