| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00321-1 |
| Product Name/Description |
FreeStyle InsuLinx Blood Glucose Meter (An in vitro diagnostic medical device (IVD))
List Number: 71236.70
All lots
ARTG number: 193995 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Abbott have determined that at extremely high blood glucose levels (56.8 mmol/L and above), the device will display and store in memory an inaccurate low result that is 56.8 mmol/L below the genuine result. For example, for a blood glucose result of 59.1 mmol/L, the meter will display and store a result of 2.3 mmol/L (59.1 mmol/L - 56.8 mmol/L = 2.3 mmol/L). If this occurs there may be a delay in identification and treatment of high blood glucose levels, or incorrect treatment may be recommended by the insulin calculator, if this feature is enabled on the meter. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbot Diabetes Care has developed a software correction for the problem and is asking users with access to the internet to update the software of the device. For more details, http://www.tga.gov.au/safety/alerts-device-freestyle-insulinx-130417.htm . |
| Contact Information |
1800 639 505 - Abbott Diabetes Cares Customer Service |