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ACCU-CHEK INFORM II + RF METER (2015-05-29)
- Starting date:
- May 29, 2015
- Posting date:
- July 8, 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-54098
Recalled Product
A. ACCU-CHEK INFORM II + RF METER
Reason
The manufacturer has documented a new operating temperature claim that will be included in the next version of the operator's manual of the Accu-Chek Inform II + RF Meter. The "operating temperature" was changed from 3c-50c to 3c-42c.
Affected products
A. ACCU-CHEK INFORM II + RF METER
Lot or serial number
>10. Contact mfr.
Model or catalog number
05060303001
Companies
- Manufacturer
-
Roche Diagnostics Gmbh
Sandhoferstrasse 116
Mannheim
68305
GERMANY