Nipro TRUEtrack and TRUEbalance blood glucose meters

Related information

Recall - replacement due to potential for miscalibration

1 November 2013

Consumers and health professionals are advised that Nipro Australia, in consultation with the TGA, is recalling some models of its TRUEtrack and TRUEbalance blood glucose meters and replacing them with updated devices.

Nipro TRUEtrack and TRUEbalance blood glucose meters are primarily used for self-testing by patients with diabetes.

It has been identified that a small number of TRUEbalance and TRUEtrack blood glucose meters may have been incorrectly calibrated with the wrong unit of measure. Specifically, a miscalibrated meter would use mg/dL instead of mmol/L, which is the standard unit used in Australia.

Nipro TRUEtrack measuring kit Nipro TRUEbalance blood glucose meter

If a patient did not notice the incorrect unit of measure, the meter result could be misread as being higher than the true figure. If this occurs, there is a risk of incorrect treatment including overmedication.

There had been no reports of adverse events related to this issue in Australia as at 23 October 2013.

The serial numbers of affected meters are:

TRUEtrack
4176182 4177334 4177782 4177785
4176183 4177335 4177784 4186184
4354708 6432741 6434619 6434635
4641738 6432743 6434620 6438140
5691817 6432744 6434632 6438160
5691871 6434617 6434633 6438165
6408716 6434618 6434634 6438180
TRUEbalance
B0305081 B0305100 B0800463 B0991386
B0305082 B0579038 B0800464 B0991521
B0305083 B0579039 B0800465 B0991524
B0305084 B0579040 B0919184 B0991582
B0305085 B0586781 B0921887 B0992982
B0305086 B0586782 B0924863 B0993507
B0305087 B0586783 B0931616 B0993508
B0305088 B0586784 B0989725 B0993509
B0305089 B0587503 B0984142 B0996186
B0305091 B0587504 B0989840 B0993630
B0305092 B0567945 B0984141 B0995344
B0305093 B0567949 B0989839 B0995492
B0305094 B0767111 B0932924 B0995493
B0305095 B0768497 B0989838 B0995494
B0305096 B0768498 B0932321 B0995496
B0305097 B0768499 B0989837
B0305098 B0768583 B0991301
B0305099 B0768712 B0991304

No other blood glucose meters manufactured by Nipro Diagnostics are affected by this recall.

Information for consumers

This recall affects a number of TRUEtrack and TRUEbalance blood glucose meters that were distributed to NSW and Queensland patients by Diabetes Australia - NSW (now known as the Australian Diabetes Council). Nipro Australia has contacted all affected consumers to provide further information and to arrange replacement of their meters.

To confirm whether or not you have an affected device, check the serial number on the label on the back of the meter against the above list. If you think you may have an affected device but have not been contacted, or if you have any other questions, call Nipro Australia on 1800 451 737.

If you have an affected device, you should use an alternative method for measuring your blood glucose levels.

You can continue to use other blood glucose meters manufactured by Nipro Diagnostics that are not affected by this recall. However, you should only use test strips that are intended for use with your particular device.

Information for health professionals

If you supply TRUEtrack or TRUEbalance blood glucose meters, you should check the lot numbers (printed on the outer case/shipper label or on the side of the meter box) of any devices you have in your inventory. The affected lot numbers are published below and the serial numbers of affected meters contained within those lots are listed in the main section above.

If you have any TRUEtrack or TRUEbalance blood glucose meters from those lots, contact Nipro Australia on 1800 451 737 to arrange return and replacement of those devices.

If you are treating a patient who may be using an affected TRUEtrack or TRUEbalance blood glucose meter, advise them of this issue. If they do have an affected device, advise them to use an alternative method for measuring their blood glucose levels and to contact Nipro Australia on 1800 451 737 for further information.

Patients can continue to use other blood glucose meters manufactured by Nipro Diagnostics that are not affected by this recall. However, they should only use test strips that are intended for use with their particular device.

The lot numbers of affected meters are:

TRUEtrack (models A4108-81 and A4108-83)
KJ0139-1 KJ0708-1 KM0504TI
KJ0318-2 KM0421TI KL0229
TRUEbalance (models H4101-91BK and H4108-81)
KL0892 KM1321TI KN1612TI
KM0726TI KN1138TI

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.