PRA number
2016/15502
Published date
Product description
TRUEresult blood glucose test strips are used with the TRUEresult blood glucose monitoring system by people with diabetes to measure blood sugar levels.
Reasons the product is recalled
It has been identified that some of the test strips from the affected batch may have been contained within an open test strip vial. Being exposed to the outside environment can affect test strip performance and lead to false low readings.
The hazards to consumers
If this occurs, the patient could experience undetected hyperglycaemia (high blood sugar), which may lead to improper treatment. Treatment based on false low readings can raise blood sugar levels further and lead to hyperglycaemia (high blood sugar) that may require medical intervention.
What consumers should do
If you or someone you care for uses TRUEresult blood glucose test strips, please be aware of this issue.
Check any unused test strips to see if they are from batch number KS1741, with expiry date 25/06/2018. The batch number is displayed at the bottom of the left side of the package.
If you have test strips from the affected batch, do not use them. Test your blood sugar level with test strips from an unaffected batch or use an alternative device.
If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.
Check any unused test strips to see if they are from batch number KS1741, with expiry date 25/06/2018. The batch number is displayed at the bottom of the left side of the package.
If you have test strips from the affected batch, do not use them. Test your blood sugar level with test strips from an unaffected batch or use an alternative device.
If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.
Supplier
Nipro Australia Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.