| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01079-1 |
| Product Name/Description |
TRUEtrack and TRUEbalance Blood Glucose Monitoring Systems |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
30/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
As part of Nipro Diagnostics internal manufacturing process Blood Glucose Meters are required to be reconfigured to meet country specific requirements. During the reconfiguration process, the unit of measure was set incorrectly on a small subset of TRUEbalance and TRUEtrack meters supplied in Australia. Specifically, a miscalibrated meter would use mg/dL instead of mmol/L, which is the standard unit used in Australia.
This recall was initiated by Nipro Australia prior to consulting with the TGA. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Nipro is advising users to check the serial number on the back of the meter to identify if their meter is affected. An alternative method for measuring blood glucose levels should be used if you have an affected meter. Affected meters can be returned to Nipro for a replacement unit. For more details, please see http://tga.gov.au/safety/alerts-device-nipro-glucose-meter-131031.htm . |
| Contact Information |
1800 451 737 - Nipro Australia |