Nipro Australia Pty Ltd—TRUEresult Blood Glucose Test Strip

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.
trueresult-blood-glucose-test-strips
Identifying features
The affected batch number is KS1741, with expiry date 25/06/2018.

Other identifying numbers

The affected batch number is KS1741, with expiry date 25/06/2018.

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.

Supplier

Nipro Australia Pty Ltd

Where the product was sold

Nationally

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category

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