Planned maintenance may cause outages to the Department of Health and Aged Care’s network from 5:15 pm AEDT on 30 November to 10:00 pm AEDT on 1 December 2024. Access to TGA databases such as TBS Portal, ARTG and DAEN may be affected. We apologise for any inconvenience.
| 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: |
| |||||||||||||||
| 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. | |||||||||||||||
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.