| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00243-1 |
| Product Name/Description |
One Touch Verio IQ Blood Glucose Monitoring System
Product Code: 02258801
ARTG Number: 200176 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/03/2013 |
| Responsible Entity |
|
| Reason/Issue |
At extremely high blood glucose levels of 56.8 mmol/L and above, the OneTouch Verio IQ Meter will turn off instead of displaying the message "EXTREME HIGH GLUCOSE above 33.3 mmol/L" as intended. On restart the meter will enter set up mode. |
| Recall Action |
Recall |
| Recall Action Instructions |
Patients are advised to continue using their OneTouch Verio IQ meter until the replacement meter arrives. However, if the meter unexpectedly turns off and enters set-up mode after turning it back on, the patient should contact their Diabetes Nurse Educator or Health Professional as this may be an indication of extremely high blood glucose.
Distributors and health services are being advised to immediately return all affected product. |
| Contact Information |
1800 543 372 - OneTouch Customer Care Line |