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Blood glucose meter recalled: May give out wrong blood sugar levels

Starting date:
January 14, 2014
Posting date:
January 14, 2014
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-37573

Issue

Nipro Diagnostics Inc., in consultation with Health Canada, is voluntarily recalling a limited number of its "TRUEtrack" blood glucose meters as a result of a potential error in displaying blood sugar levels. The Canadian version of the affected product is currently displaying glucose levels in milligrams per decilitre (mg/dl) rather than the standard millimoles per litre (mmol/L) used in Canada.

Consumers are at risk of thinking they have obtained a higher than expected blood sugar level reading because of this incorrect factory-set unit of measure. As a result, patients may use more insulin than required, which may cause hypoglycemia (low blood sugar), and in extreme cases may cause loss of consciousness or death.

To date, Health Canada has not received any adverse reports associated with "TRUEtrack" blood glucose meters, which were distributed in Canada between July 2008 and April 2013.

Health Canada is advising consumers using the affected meters to speak either with their pharmacist or their healthcare practitioner about what other options are available to them.

The company, Nipro Diagnostics, is advising consumers to confirm if they have the affected meter by visiting its website and verifying the serial numbers on the back of the device. Nipro Diagnostics has also provided further instructions as to product replacement on its website. Consumers may also call the company toll-free at 1-866-236-4518.

Health Canada is monitoring the recall and will update Canadians should new information be identified.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709