Z-1901-2013Class I

Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max...

Name: Z-1901-2013 Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max...
Creator: Nova Biomedical Corporation
Published: 2013-07-15
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2013-07-15 / Terminated / root cause: manufacturing process

FDA source

Nova Biomedical Corporation began a recall of 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... on 2013-07-15. FDA classified it as Class I and gives the reason as "Reports of false abnormally high glucose readings from test strips". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1901-2013
Classification: Class I
Status: Terminated
Initiated: 2013-07-15
Posted: 2013-08-09
Terminated: 2017-08-01
Recalling firm: Nova Biomedical Corporation
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
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Reports of false abnormally high glucose readings from test strips
Root cause tag: manufacturing process
FDA 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 1-800-681-7390. .
Quantity in commerce: *Kitted into System Kits 43435 and 45507
Distribution: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1901-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1897-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1898-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1899-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1900-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1901-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1902-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1903-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1904-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1905-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09
Z-1906-2013	Class I	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09

Product code NBW

K091547Class IINova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max Blood GlucosNova Biomedical Corp. / cleared 2010-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)