PRA number
2011/12708
Published date
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.
Johnson and Johnson have advised the Therapeutic Goods Administration (TGA) of additional serial numbers affected by the recall.
Reasons the product is recalled
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.
The hazards to consumers
The patient may not get a blood glucose result.
What consumers should 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
•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
Supplier
Johnson & Johnson Medical Pty Ltd
Where the product was sold
Nationally
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.