Device product
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 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
Z-1901-2013
Product summary
- Event
- Event 65617
- Status
- Terminated
- Classification
- Class I
- Quantity
- *Kitted into System Kits 43435 and 45507
- Official record key
device-enforcement:Z-1901-2013
Official wording
Reason: Reports of false abnormally high glucose readings from test strips
Code information: Lot #/Exp.Date: 1020212032 02/28/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013 102121304 02/28/2015
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Derived failure modes
-
Unknown
Reports of false abnormally high glucose readings from test strips