This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Accu-Chek Aviva Combo (2013-10-31)

Starting date:
October 31, 2013
Posting date:
December 17, 2013
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-37197

Recalled products

A. Accu-Chek Aviva Combo 

Reason

This recall is related to a software synchronization issue when the manual pump option is chosen on the meter there is a possibility of receiving an incorrectly lower bolus advice resulting in temporary mild insulin under delivery.

Affected products

A. Accu-Chek Aviva Combo 

Lot or serial number

More than 10 numbers, contact manufacturer

Model or catalog number
  • 05172594003
  • 05172594004
  • 05172594005
  • 05391563001
Companies
Manufacturer
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY