Nova Max Blood Glucose Test Strips Recalled: Certain Lots May Give False High Results

Starting date:

August 6, 2013

Posting date:

August 6, 2013

Type of communication:

Information Update

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Contamination

Identification number:

RA-34883

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Issue

Health Canada is informing Canadians of a voluntary recall of certain lots of Nova Max Blood Glucose Test Strips (see list below) that were contaminated during the manufacturing process. The recall also affects unused Nova Max Plus Glucose Meter Kits, which contain test strips from the recalled lots. The test strips under recall may report a false, abnormally high blood glucose result. Under certain conditions, such a false result could lead users with diabetes to an insulin dosing error, requiring the user to seek immediate medical attention.

The test strips are sold in retail stores/pharmacies, online directly to consumers, and may be used in health care facilities.

Consumers using strips from the recalled lots should immediately stop using them and take the necessary steps to continue to monitor their blood sugar. The Canadian distributor, Nova Biomedical Canada Ltd., is providing additional guidance for customers, and Canadians can also consult their healthcare professional if they have concerns about glucose test results obtained using the strips. Patients should not make significant changes to their diabetes management program without speaking to their healthcare professional.

Healthcare professionals and pharmacists with unused kits involved in the recall should remove them from circulation immediately.

Anyone needing further information about the recall can contact Nova Diabetes Care customer service at 1‐800‐260‐1021.

Insulin dosing errors can lead to high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia). Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting, and abdominal pain. Symptoms of low blood sugar include trembling, excessive sweating, weakness, hunger, confusion, and headache. Some individuals may experience no symptoms before experiencing unconsciousness or seizures.

Nova Max Test Strip Recalled Lots

• Nova Max Test Strip (10 count vials) - Catalogue Number 43877
  • 1020211355
• Nova Max Test Strip (100 count vials) - Catalogue Number 43955
  • 1020212032
  • 1020212100
  • 1020212153
  • 1020212207
  • 1020912292
  • 1020412341
  • 1020213074

Nova Max Plus Meter Kit Recalled Lots

• 1010112073
• 1010113002
• 1010113008

Report health or safety concerns

Consumer complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

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

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