Product Wiki · Recalls · U.S. FDA — Device Enforcement

Nova Max Glucose Test Strips (50 Count International Catalog Number… — recall Z-1902-2013

U.S. FDA — Device Enforcement · United States · 2013-07-15 · Class I

As described by U.S. FDA — Device Enforcement: Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 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 th

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1902-2013
Date of alert
2013-07-15
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Nova Biomedical Corporation
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
Reported risk: Reports of false abnormally high glucose readings from test strips
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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