PlainRecalls
FDA Devices Critical Class I Terminated

Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an

Reported: August 21, 2013 Initiated: July 15, 2013 #Z-1902-2013

Product Description

Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control

Reason for Recall

Reports of false abnormally high glucose readings from test strips

Details

Units Affected
366,140 test strips
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Location
Waltham, MA

Frequently Asked Questions

What product was recalled? ▼
Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control. Recalled by Nova Biomedical Corporation. Units affected: 366,140 test strips.
Why was this product recalled? ▼
Reports of false abnormally high glucose readings from test strips
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Critical. Recall number: Z-1902-2013.

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