Medical Device Recall

Dear members

You will be receiving a letter from Johnson & Johnson early next week indicating a recall of some Blood Glucose Meters, which were distributed in Australia, in OneTouch Verio® System Kits. The distribution of the affected product occurred during the period August 2010 and April 2011. The lot numbers are listed in the attachment Click here. The lot number can be located on the box of the kit adjacent to the barcode.

You may also see the recall advertisement in your local paper. The attachment can be given to your patients/clients who may have received affected meters.

The manufacturer of OneTouch Verio® Blood Glucose Meters has identified that these meters may produce an “Error 2” message, instead of a blood glucose result, when testing in conditions of high temperature and/or humidity. This issue has no impact on the accuracy of test results produced by these meters; all readings obtained are valid and accurate readings.

The strips and the control test solution used with the meter are NOT affected by this recall.

ACTION:

                        Immediately check your inventory to determine if your facility has any affected product.

 

If you do not have any affected product

                        Complete the attached acknowledgement form and return it by fax to 1800 241 101 or email to

 

ra‐jnjau‐recallsanz@its.jnj.com

If you have affected product

                        Quarantine the affected product, prior to returning it to Johnson & Johnson Medical.

                        Record affected product on the attached acknowledgement form.

                        Return the acknowledgement form to Johnson &Johnson Medical by fax to 1800 241 101 or email to ra‐jnjau‐recallsanz@its.jnj.com.

                        Johnson & Johnson Medical Customer Service will organise pick up and replacement of the affected product free of charge

 

This recall is being undertaken following consultation with the Therapeutic Goods Administration, if you have any questions, or concerns in regards to this recall, please contact your local ONETOUCH® product specialist or ONETOUCH® Customer Care toll free 1800 543 372. We are available from 9.00am to 5.00pm AEST, Monday to Saturday message service is available out of hours.

Medical Device Recall

Dear members

You will be receiving a letter from Johnson & Johnson early next week indicating a recall of some Blood Glucose Meters, which were distributed in Australia, in OneTouch Verio® System Kits. The distribution of the affected product occurred during the period August 2010 and April 2011. The lot numbers are listed in the attachment Click here. The lot number can be located on the box of the kit adjacent to the barcode.

You may also see the recall advertisement in your local paper. The attachment can be given to your patients/clients who may have received affected meters.

The manufacturer of OneTouch Verio® Blood Glucose Meters has identified that these meters may produce an “Error 2” message, instead of a blood glucose result, when testing in conditions of high temperature and/or humidity. This issue has no impact on the accuracy of test results produced by these meters; all readings obtained are valid and accurate readings.

The strips and the control test solution used with the meter are NOT affected by this recall.

ACTION:

                        Immediately check your inventory to determine if your facility has any affected product.

 

If you do not have any affected product

                        Complete the attached acknowledgement form and return it by fax to 1800 241 101 or email to

 

ra‐jnjau‐recallsanz@its.jnj.com

If you have affected product

                        Quarantine the affected product, prior to returning it to Johnson & Johnson Medical.

                        Record affected product on the attached acknowledgement form.

                        Return the acknowledgement form to Johnson &Johnson Medical by fax to 1800 241 101 or email to ra‐jnjau‐recallsanz@its.jnj.com.

                        Johnson & Johnson Medical Customer Service will organise pick up and replacement of the affected product free of charge

 

This recall is being undertaken following consultation with the Therapeutic Goods Administration, if you have any questions, or concerns in regards to this recall, please contact your local ONETOUCH® product specialist or ONETOUCH® Customer Care toll free 1800 543 372. We are available from 9.00am to 5.00pm AEST, Monday to Saturday message service is available out of hours.