01.Life Scan One Touch Verio Blood Glucose monitoring System recall - re-announced
Product description
Life Scan One Touch Verio Blood Glucose Monitoring System (primarily used for self testing by patients with diabetes)
Johnson and Johnson have advised the Therapeutic Goods Administration (TGA) of additional serial numbers affected by the recall.
Identifying features
Part Number 022-186-01
The units affected were manufactured during August 2010 to December 2010 and are being recalled. The additional units affected were manufactured on or before 4 January 2011 and are being recalled.
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
What are the hazards?
The patient may not get a blood glucose result.
What are the defects?
Some Life Scan One Touch Verio Blood Glucose Monitoring Systems are giving repeated 'error 2' warning messages when used in conditions of high temperature and/or humidity.
Where the product was sold
Nationally
Supplier
Johnson & Johnson Medical Pty Ltd
What should consumers do?
• If the affected unit does not give the error message, then the reading is reliable.
• Patients with Life Scan One Touch Verio Blood Glucose Monitoring System should contact the One Touch Customer Care line 1800 543 372 to have the affected units replaced and to get more information.
• The replacement with an unaffected meter of the same model will be provided at no cost.
• The strips and the control test solution used with this meter are not affected by this recall.
• Information on how to report a suspected problem with a medicine or medical device to the TGA can be found at : http://www.tga.gov.au/consumers/problem.htm
Other regulator reference numbers
RC-2011-RN-00611-3