Health product recall

Nova Statstrip® Ketone Test Strips

Last updated

Summary

Product
Nova Statstrip® Ketone Test Strips
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Nova Statstrip® Ketone Test Strips

2224295249

66841

Nova Statstrip® Ketone Test Strips

2226117249

66841

Issue

Certain lots of StatStrip Ketone Test Strips were found to have an increased rate of quality control (QC) test failures during use. While patient whole-blood testing performance is not affected, the affected lots are being recalled to prevent delays in obtaining ketone test results. Users should immediately identify and discontinue their use, and follow the instructions provided in the recall notification. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Nova Biomedical Corporation

200 Prospect St., Waltham, Massachusetts, United States, 02454

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82918

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