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
FDA Recall Z-1902-2013 · Posted 2013-08-09
Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeNBW
Date Initiated2013-07-15
Date Terminated2017-08-01
Product Quantity366,140 test strips
Reason for Recall
Reports of false abnormally high glucose readings from test strips
Firm Action
Nova Biomedical U.S.A issued an Urgent Medical Device Voluntary Recall Letter dated July 19, 2013 via registered/certified letters to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use of the affected product; contact Nova Diabetes Care Customer Service for replacement strips; do not stop testing blood glucose while waiting for replacement strips; if affected strips must be used follow precautions provided in notification letter. For questions call Nova Diabetes Care Customer Service at 1-800-681-7390.
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Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.