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LIAISON System - H. Pylori SA (2014-12-30)
- Starting date:
- December 30, 2014
- Posting date:
- January 9, 2015
- 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-43181
Recalled Products
LIAISON System - H. Pylori SA
Reason
The LIAISON H. Pylori SA kit reports an incorrect volume for the sample diluent component. The kit content states 40ml and specimen diluent component contains 45mls. The component label and instructions for use are correct at 45ml.
Affected products
LIAISON System - H. Pylori SA
Lot or serial number
131211A
131211B
Model or catalog number
318920
Companies
- Manufacturer
-
Diasorin Inc.
1951 Northwestern Ave. P.O. Box 285
Stillwater
55082
Minnesota
UNITED STATES