Sub menu

 

 

LifeScan OneTouch Verio blood glucose monitoring system (recall notice), Jun 2011

Urgent medical device recall

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.

Published
Level:Consumer
Class:II
Reference:RC-2011-RN-00611-3
Date agreed:14 June 2011
Product:LifeScan OneTouch Verio Blood Glucose Monitoring System, manufactured by LifeScan Inc, USA during August 2010 to December 2010.  (Multiple serial numbers affected)
ARTG number:168174
Batch number:
The first 5 letters of affected device serial numbers
BOBNQBOBPMBOBQJBOBRFBOBSBBOBSXBOBTTBOBVQBOBWM
BOBNRBOBPNBOBQKBOBRGBOBSCBOBSZBOBTVBOBVRBOBWN
BOBNSBOBPPBOBQLBOBRHBOBSDBOBTBBOBTWBOBVSBOBWP
BOBNTBOBPQBOBQMBOBRJBOBSFBOBTCBOBTXBOBVTBOBWQ
BOBNVBOBPRBOBQNBOBRKBOBSGBOBTDBOBTZBOBVVBOBWR
BOBNWBOBPSBOBQPBOBRLBOBSHBOBTFBOBVBBOBVWBOBWS
BOBNXBOBPTBOBQQBOBRMBOBSJBOBTGBOBVCBOBVXBOBWT
BOBNZBOBPVBOBQRBOBRNBOBSKBOBTHBOBVDBOBVZBOBWV
BOBPBBOBPWBOBQSBOBRPBOBSLBOBTJBOBVFBOBWBBOBWW
BOBPCBOBPXBOBQTBOBRQBOBSMBOBTKBOBVGBOBWCBOBWX
BOBPDBOBPZBOBQVBOBRRBOBSNBOBTLBOBVHBOBWDBOBWZ
BOBPFBOBQBBOBQWBOBRSBOBSPBOBTMBOBVJBOBWFBOBXB
BOBPGBOBQCBOBQXBOBRTBOBSRBOBTNBOBVKBOBWGBOBXC
BOBPHBOBQDBOBQZBOBRVBOBSSBOBTPBOBVLBOBWHBOBXD
BOBPJBOBQFBOBRBBOBRWBOBSTBOBTQBOBVMBOBWJBOBXF
BOBPKBOBQGBOBRCBOBRXBOBSVBOBTRBOBVNBOBWKBOBXG
BOBPLBOBQHBOBRDBOBRZBOBSWBOBTSBOBVPBOBWL 
Sponsor:Johnson & Johnson Medical Pty Ltd
Contact:1800 543 372 - OneTouch customer care line
Reason: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.

Product types