PRA number
2019/17979
Published date
Product description
Accu-Chek Guide Meter
Serial Numbers below 92911000001
ARTG 190250
Accu-Chek Performa Meter
Serial Numbers between 68920000000 and 68925525056
ARTG 190250
Accu-Chek Guide Meter Kit
Serial Numbers below 92911000001
ARTG 273957
Accu-Chek blood glucose meters. An in vitro diagnostic medical device (IVD)
Serial Numbers below 92911000001
ARTG 190250
Accu-Chek Performa Meter
Serial Numbers between 68920000000 and 68925525056
ARTG 190250
Accu-Chek Guide Meter Kit
Serial Numbers below 92911000001
ARTG 273957
Accu-Chek blood glucose meters. An in vitro diagnostic medical device (IVD)
Reasons the product is recalled
The Accu-Chek Guide and Performa blood glucose meters may show the following power-related issues:
- Display E-9 Errors (indicating batteries need to be replaced)
- Unexpectedly show the low battery icon
- Have unexpected short battery life
- Not power on
Power issues such as those listed may result in a temporary meter unavailability for the user.
- Display E-9 Errors (indicating batteries need to be replaced)
- Unexpectedly show the low battery icon
- Have unexpected short battery life
- Not power on
Power issues such as those listed may result in a temporary meter unavailability for the user.
The hazards to consumers
If users are unable to monitor blood glucose levels to determine the insulin dose or make treatment decisions, this may lead to incorrect dosing decisions, which can lead to serious health complications.
What consumers should do
Roche will contact affected customers in writing. Customers are advised to follow the instructions provided in the customer letter and the following warnings:
1. Always have a spare set of high quality batteries
2. Battery life may vary due to factors such as temperature and battery manufacturer
3. Have a back-up testing method available
Further information can be obtained from the website at https://www.accu-chek.com.au/#alerts
For further information, contact the Roche Diabetes Care Enquiry line on 1800 251 816
1. Always have a spare set of high quality batteries
2. Battery life may vary due to factors such as temperature and battery manufacturer
3. Have a back-up testing method available
Further information can be obtained from the website at https://www.accu-chek.com.au/#alerts
For further information, contact the Roche Diabetes Care Enquiry line on 1800 251 816
Traders who sold this product
Pharmacies and Chemists
Where the product was sold
Nationally
International
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.