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Devyser AZF
- Starting date:
- December 2, 2016
- Posting date:
- January 18, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61836
Reason
Sale of unlicensed class III medical device in Canada. Devyser AZF (8-A019) Kits were incorrectly labelled In Vitro Diagnostics (IVD) instead of Research Use Only (RUO).
Affected products
Devyser AZF
Lot or serial number
GTIN 7350040630280
Model or catalog number
8-A019
Companies
- Manufacturer
-
DEVYSER AB
INSTRUMENTVAGEN, 19, SE-12653 HAGERSTEN
SWEDEN