Recall Z-1902-2013
Nova Biomedical Corporation · initiated July 15, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
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
Codes / lots: Lot #/Exp.Date: 1020112086 03/31/2014 1020212032 02/28/2014 1020213074 03/31/2015 1020213109 04/30/2015
Reason for recall
Reports of false abnormally high glucose readings from test strips
FDA-determined cause: Material/Component Contamination
Action taken
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. .
Details
- Recall number
- Z-1902-2013
- Initiated
- July 15, 2013
- Posted by FDA
- August 9, 2013
- Terminated
- August 1, 2017
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 366,140 test strips
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
- Recalling firm
- Nova Biomedical Corporation, Waltham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1897-2013 Class I | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1898-2013 Class I | Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1899-2013 Class I | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1900-2013 Class I | Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1901-2013 Class I | Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1903-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage:…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1904-2013 Class I | Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1905-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |
| Z-1906-2013 Class I | Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507…Reports of false abnormally high glucose readings from test strips | 07/15/2013Terminated |