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

Urgent medical device recall

16 June 2011
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
BOBNQ BOBPM BOBQJ BOBRF BOBSB BOBSX BOBTT BOBVQ BOBWM
BOBNR BOBPN BOBQK BOBRG BOBSC BOBSZ BOBTV BOBVR BOBWN
BOBNS BOBPP BOBQL BOBRH BOBSD BOBTB BOBTW BOBVS BOBWP
BOBNT BOBPQ BOBQM BOBRJ BOBSF BOBTC BOBTX BOBVT BOBWQ
BOBNV BOBPR BOBQN BOBRK BOBSG BOBTD BOBTZ BOBVV BOBWR
BOBNW BOBPS BOBQP BOBRL BOBSH BOBTF BOBVB BOBVW BOBWS
BOBNX BOBPT BOBQQ BOBRM BOBSJ BOBTG BOBVC BOBVX BOBWT
BOBNZ BOBPV BOBQR BOBRN BOBSK BOBTH BOBVD BOBVZ BOBWV
BOBPB BOBPW BOBQS BOBRP BOBSL BOBTJ BOBVF BOBWB BOBWW
BOBPC BOBPX BOBQT BOBRQ BOBSM BOBTK BOBVG BOBWC BOBWX
BOBPD BOBPZ BOBQV BOBRR BOBSN BOBTL BOBVH BOBWD BOBWZ
BOBPF BOBQB BOBQW BOBRS BOBSP BOBTM BOBVJ BOBWF BOBXB
BOBPG BOBQC BOBQX BOBRT BOBSR BOBTN BOBVK BOBWG BOBXC
BOBPH BOBQD BOBQZ BOBRV BOBSS BOBTP BOBVL BOBWH BOBXD
BOBPJ BOBQF BOBRB BOBRW BOBST BOBTQ BOBVM BOBWJ BOBXF
BOBPK BOBQG BOBRC BOBRX BOBSV BOBTR BOBVN BOBWK BOBXG
BOBPL BOBQH BOBRD BOBRZ BOBSW BOBTS BOBVP BOBWL  
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.