| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00167-1 |
| Product Name/Description |
FreeStyle Papillon Mini Blood Glucose Monitoring System
List Number: 70728.01
ARTG Number: 126412 (cancelled by the sponsor) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
20/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or give blood glucose results which could affect clinical outcome or have significant medical risk when used in conjunction with any FreeStyle test strip lot within expiry.br /br /This is an update to the recall initiated in November 2013 on certain lots of FreeStyle Blood Glucose Test Strips (RC-2013-RN-01228-1). The FreeStyle Papillion Mini blood glucose monitoring system has not been supplied in Australia since 2009.br /br /Further inforamtion on this recall can be found at http://www.tga.gov.au/safety/alerts-device-freestyle-strips-papillon-mini-140304.htm |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott is providing consumers who are still the possession of of a FreeStyle Papillion Mini blood glucose meter with a replacement FreeStyle branded meter. |
| Contact Information |
1800 801 478 - Abbott Diabetes Care Customer Service |