Health product recall

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