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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
BOCBF BOCBH BOCBQ BOCBR BOCCC
BOCBG BOCBJ BOCBB BOCCB BOCCF
Sponsor: Johnson & Johnson Medical Pty Ltd
Contact: 1800 543 372 - OneTouch customer care line
Reason:

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.