Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Stri

FDA device recall Z-1902-2013 · posted 2013-08-09 · Terminated

Recall details

Recalling firm

Nova Biomedical Corporation

Reason for recall

Reports of false abnormally high glucose readings from test strips

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. .

Root cause

Material/Component Contamination

Status

Terminated

Product code

NBW

Quantity affected

366,140 test strips

Distribution

Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua

Date initiated

2013-07-15

Date posted

2013-08-09

Date terminated

2017-08-01

Location

Waltham, MA

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