Safety Information

Alert Communication

Recall of KetoSens Test Strips – batch UJ03PBXNG

05 September 2022

KetoSens Test Strips batch UJ03PBXNG is being recalled because it may give false readings. The test results may show that the patient has higher ketone levels than their actual levels.

Patients should return any KetoSens Test Strips with the affected batch number to wherever they were obtained from (may be a pharmacy) for a replacement.

This recall does not affect any other batches of KetoSens Test Strips.

Advice for patients
Products affected
Additional information
Regulator actions
Reporting

Advice for patients

If you received KetoSens Test Strips batch UJ03PBXNG, please return any unused strips to wherever they were obtained from (may be a pharmacy) for a replacement.

Alternatively, you can contact Pharmaco for collection and replacement:

Pharmaco (NZ) Limited
Phone: 0800 80 4079
Email: recall@pharmaco.co.nz

If you have any medical queries or concerns about your health or have had a high reading while using a strip from this batch, please speak to your health care professional for advice.

This recall does not affect any other batches of KetoSens Test Strips. You can continue to use test strips from other batches.

Products affected

Product name	Sponsor
KetoSens Test Strips, batch UJ03PBXNG	Pharmaco (NZ) Ltd

KetoSens test strips are used with the CareSens Dual system for measuring the β-ketone levels in capillary whole blood. Together, they help with diabetes management at home or in clinical settings.

Additional information

The batch number is on the back of the pack (Figure 1).

Figure 1: Image of the KetoSens Test Strips pack showing the location of the batch number

The affected batch has only been available in New Zealand since 25 July 2022.

Following reports of false high ketone readings, i-SENS (the product manufacturer) tested strips from batch UJ03PBXNG and found that some strips from this batch gave incorrect readings. i-SENS also tested other batches, and they gave correct ketone readings.