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 |
|
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 |