Recall Z-1902-2013 ยท NBW System, Test, Blood Glucose, Over The Counter
Nova Biomedical Corporation
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 peop
| Date | Aug 9, 2013 (initiated Jul 15, 2013) |
| Status | Terminated |
| Reason | Reports of false abnormally high glucose readings from test strips |
| Root cause | Material/Component Contamination |
| 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 |
| Quantity | 366,140 test strips |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091547 | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS Nova Biomedical Corp., Jan 15, 2010 |