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LifeScan OneTouch Verio blood glucose meter system kits (recall notice), Sep 2011
Urgent medical device recall
|Date agreed:||16 September 2011|
|Product:||OneTouch Verio Blood Glucose Meter System kits manufactured by LifeScan Inc, USA. (Multiple serial numbers affected)|
|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.
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.