Accu-Chek Inform II Test Strips (2018-05-07)
- Starting date:
- May 7, 2018
- Posting date:
- May 25, 2018
- 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-66846
Affected products
Accu-Chek Inform II Test Strips
Reason
The Accu-Chek Inform II Test Strips (Cat # 05942861164, lot 476653) was identified to not meet product specifications. Higher than expected amount of strips errors before dosing and in very limited cases, an increase potential for biased results could be observed.
Affected products
Accu-Chek Inform II Test Strips
Lot or serial number
476653
Model or catalog number
05942861164
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
68305
GERMANY