Health product recall

Dario Blood Glucose Tracker (2019-08-30)

Starting date:
August 30, 2019
Posting date:
October 3, 2019
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-71135



Last updated: 2019-10-03

Affected Products

Dario Blood Glucose Tracker

Reason

Labstyle Innovation LTD has identified a potential issue with android app versions of Dario Blood Glucose Tracker (4.3.0-4.3.2). The issue may cause blood glucose (BG) readings that are transferred from the measurement screen to the 'LOGBOOK' to may be replaced by an older measurement and be displayed as duplicated reading.

Affected products

Dario Blood Glucose Tracker

Lot or serial number

Version 4.3.0-4.3.2

Model or catalog number

1015-01

Companies
Manufacturer

LABSTYLE INNOVATIONS LTD.

9 HALAMISH STREET

NORTH INDUSTRIAL APRK, CAESAREA

3890000

ISRAEL