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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01228-1
Product Name/Description FreeStyle Lite Blood Glucose Test Strips (used with FreeStyle Papillon Mini Blood Glucose Meters). An in vitro diagnostic medical device (IVD)

Product Number: 70984.70

Lot Numbers: 1366540, 1366621
Recall Action Level Consumer
Recall Action Classification Class II
Recall Action Commencement Date 20/11/2013
Responsible Entity Abbott Australasia Pty Ltd T/A Abbott Diabetes Care
Reason/Issue The affected FreeStyle Lite Blood Glucose Test Strips may produce erroneously low blood glucose results and out of range control solution results when used with the FreeStyle Papillon Mini Blood Glucose Meters.

Blood glucose results are not affected if using the FreeStyle Lite Blood Glucose Monitoring System, FreeStyle Insulinx, Blood Glucose Monitoring System or FreeStyle Freedom Lite Blood Glucose Monitoring System.
Recall Action Recall
Recall Action Instructions Consumers are requested to contact Abbott Diabetes Care immediately to organise replacement of the affected test strips. If no alternative test method is available customers should continue to use the affected lots and contact their healthcare professionals in the event of a reading that appears lower than expected. For further information, please see http://www.tga.gov.au/safety/alerts-device-freestyle-lite-blood-glucose-test-strips-131122.htm
Contact Information 1800 801 478 - Abbott Diabetes Care Customer Service