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LifeScan OneTouch Verio blood glucose monitoring system, 16 June 2011
- Alert: LifeScan OneTouch Verio blood glucose monitoring system
16 September 2011
- Recall notice: LifeScan OneTouch Verio blood glucose meter system kits
16 September 2011
- Recall notice: LifeScan OneTouch Verio blood glucose monitoring system
16 June 2011
Primarily used for self testing by patients with diabetes
The Therapeutic Goods Administration (TGA) has been advised that some LifeScan OneTouch Verio Blood Glucose Monitoring Systems are giving repeated 'error 2' warning messages when used in conditions of high temperature and/or humidity. In these conditions the patient may not get a blood glucose result.
The units affected were manufactured during August 2010 to December 2010 and are being recalled.
- If the affected unit does not give the error message, then the reading is reliable.
- Patients with LifeScan OneTouch Verio Blood Glucose Monitoring System should contact the OneTouch Customer Care line 1800 543 372 to have the affected units replaced and to get more information.
- The replacement with an unaffected meter of the same model will be provided at no cost.
- The strips and the control test solution used with this meter are not affected by this recall.
- Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at 'Reporting Problems'.
As of 20 May 2011, 186 complaints (179 from Australia and 7 from overseas) have been received by the manufacturer which relate to the 'error 2' message.
Investigation by the manufacturer, LifeScan Inc, USA has shown that the problem is caused by contamination occurring across the Strip Port connector (SPC) pins of the meter. This manufacturing fault is due to the use of incorrect solder wire.
The Australian supplier, Johnson & Johnson Medical Pty Ltd will advertise information about the recall in major daily newspapers in all States and Territories from Friday 17 June 2011.