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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 12/31/2013 1010512157 03/31/2014 1010512212 03/31/2014 1010512262 07/31/2014 1010512269 07/31/2014 1010512312 09/30/2014 1010513085 12/31/2014 1010513101 01/31/2015 1010513171 04/30/2015 1010612095 02/28/2014 1010612157 03/31/2014 1010612262 07/31/2014 1010612312 07/31/2014 1010612339 09/30/2014 1010613085 10/31/2014 1010613171 04/30/2015 1010712157 03/31/2014 1010712262 07/31/2014 1010713079 12/31/2014 1010713085 12/31/2014 1010813085 12/31/2014 1010912254 05/31/2014 1011113007 09/30/2014
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nova Biomedical Corporation
- Reason for Recall:
- Reports of false abnormally high glucose readings from test strips
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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 12/31/2013 1010512157 03/31/2014 1010512212 03/31/2014 1010512262 07/31/2014 1010512269 07/31/2014 1010512312 09/30/2014 1010513085 12/31/2014 1010513101 01/31/2015 1010513171 04/30/2015 1010612095 02/28/2014 1010612157 03/31/2014 1010612262 07/31/2014 1010612312 07/31/2014 1010612339 09/30/2014 1010613085 10/31/2014 1010613171 04/30/2015 1010712157 03/31/2014 1010712262 07/31/2014 1010713079 12/31/2014 1010713085 12/31/2014 1010813085 12/31/2014 1010912254 05/31/2014 1011113007 09/30/2014
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1903-2013
Related Recalls
StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
Nova Biomedical
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current glucose test result to the DMS. The risk of this software defect is erroneously high or low glucose results being documented in a patient's medical record, which may lead to incorrect treatment.
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.