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LifeScan OneTouch Verio blood glucose meter system kits (recall notice), Sep 2011

Urgent medical device recall

16 September 2011
Level: Consumer
Class: II
Reference: RC-2011-RN-00924-3
Date agreed: 16 September 2011
Product: OneTouch Verio Blood Glucose Meter System kits manufactured by LifeScan Inc, USA. (Multiple serial numbers affected)
ARTG number: 168174
Batch number:
The first five letters of serial device numbers that may be affected by this recall
Sponsor: Johnson & Johnson Medical Pty Ltd
Contact: 1800 543 372 - OneTouch customer care line

Additional devices have been identified as being affected by the 'Error 2' message.

Users are experiencing repeated 'Error 2' warning messages when used in conditions of high temperature and/or humidity due to contamination on one of the meter's components, which occurred during the manufacturing process.

If you have a OneTouch Verio Blood Glucose Meter with a serial number which begins with the first 5 letters listed above, please call the OneTouch customer care line to have the meter returned and replaced.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.