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Accu-chek Mobile Monitor (2014-05-29)
- Starting date:
- May 29, 2014
- Posting date:
- August 8, 2014
- 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-40985
Recalled products
- Accu-chek Mobile Monitor
Reason
During an internal investigation of customer complaints, the manufacturer has identified that customers have not used the system in the described and labelled handling instructions and due to this inappropriate handling, experienced falsely elevated blood glucose readings.
Affected products
A. Accu-chek Mobile Monitor
Lot or serial number
All serial numbers.
Model or catalog number
- 05349893119
- 05367727001
- 06383645119
- 07018975001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY