Recall Z-1903-2013
Nova Biomedical Corporation · initiated July 15, 2013
Class I – dangerous or defective products that could cause serious health problems or death
Product
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 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: Kit Lot/Exp: 1010112004 10/31/2013 1010112038 10/31/2013 1010112109 02/28/2014 1010112121 02/28/2014 1010112159 02/28/2014 1010112228 05/31/2014 1010112289 07/31/2014 1010113016 09/30/2014 1010113052 12/31/2014 1010113134 12/31/2014 1010113177 03/31/2015 1010212046 10/31/2013 1010212109 02/28/2014 1010212121 12/31/2013 1010212143 02/28/2014 1010212206 03/31/2014 1010212228 03/31/2014 1010212289 07/31/2014 1010212354 09/30/2014 1010213016 09/30/2014 1010213052 12/31/2014 1010213134 09/30/2014 1010312016 10/31/2013 1010312025 10/31/2013 1010312046 10/31/2013 1010312095 02/28/2014 1010312121 03/31/2014 1010312171 03/31/2014 1010312180 03/31/2014 1010312207 03/31/2014 1010312228 05/31/2014 1010312262 06/30/2014 1010312289 07/31/2014 1010312312 09/30/2014 1010312354 09/30/2014 1010313016 09/30/2014 1010313052 12/31/2014 1010313101 12/31/2014 1010313128 01/31/2015 1010313134 01/31/2015 1010411355 10/31/2013 1010412016 10/31/2013 1010412046 10/31/2013 1010412066 10/31/2013 1010412093 12/31/2013 1010412095 10/31/2013 1010412121 03/31/2014 1010412262 03/31/2014 1010412312 09/30/2014 1010413101 01/31/2015 1010413134 01/31/2015 1010413171 04/30/2015 1010512016 10/31/2013 1010512095…
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-1903-2013
- 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
- 1,316,420 kits
- 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-1902-2013 Class I | Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product…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 |