This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Rota-strip Test Kit (2014-08-25)
- Starting date:
- August 25, 2014
- Posting date:
- September 22, 2014
- 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-41449
Recalled products
- Rota-strip Test Kit
Reason
The intensity of the rotavirus test line signals generated by the incriminated rota positive control could be judged too weak. As a consequence, one may erroneously conclude that the tested diagnostic kit quality is beyond the expectations and that weak positive signals could be missed with clinical samples.
Affected products
A. Rota-strip Test Kit
Lot or serial number
- BATCH #1081G1408
- BATCH #1081G1408
Model or catalog number
- C-1081
- C-1081
Companies
- Manufacturer
-
Coris Bioconcept,
Science Park Crealys, Rue Jean Sonet 4A,
Gembloux,
5032
BELGIUM