FDAClass IAugust 21, 2013

Nova Max Plus Monitor System recall

Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use…

Why was Nova Max Plus Monitor System recalled?

Reports of false abnormally high glucose readings from test strips

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1010112059 12/31/2013 1010213171 04/30/2015 1010312066 12/31/2013 1010712339 10/31/2014

Product
Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Number: 45507 Product Usage: The Nova Max Glucose Test Strips are for use…
Recalling firm
Nova Biomedical Corporation
Quantity
13,600 kits
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Recall date
August 21, 2013
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls