Recall Z-1898-2013— Nova Biomedical Corporation
Class I · Terminated
Class I FDA medical device recall by Nova Biomedical Corporation, initiated 2013-07-15, terminated 2017-08-01. It names one FDA 510(k) clearance: K091547. Product: Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 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. Reason: Reports of false abnormally high glucose readings from test strips.
- Recalling firm
- Nova Biomedical Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-07-15
- Terminated
- 2017-08-01
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 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
Reason for recall
Reports of false abnormally high glucose readings from test strips
Data sourced from openFDA. This site is unofficial and independent of the FDA.