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ACCU-CHEK AVIVA METER (2015-03-17)
- Starting date:
- March 17, 2015
- Posting date:
- April 30, 2015
- 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-53149
Recalled Products
A. ACCU-CHEK AVIVA METER
Reason
Due to recent regulatory changes from multiple to single use, the new Accu-Chek Aviva launched in the market in 2014 is not suitable for in vitro diagnostic use by healthcare professionals in a clinical setting.
Affected products
A. ACCU-CHEK AVIVA METER
Lot or serial number
All lots.
Model or catalog number
05911966002
06870295001
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY