Recall of a single lot of the medical device OneTouch GlucoTouch test band for measuring the blood glucose level
22.02.2010
Medical Device Registration Holder in Croatia, Johnson & Johnson S.E., d.o.o., informed the Agency for Medicinal Products and Medical Devices that a Field Safety Corrective Action was under way in connection with the lot no. 2982534 of the medical device OneTouch GlucoTouch test bands for measuring blood glucose levels of the manufacturer LifeScan Inc., USA.
The manufacturer recalled the said lot of the OneTouch GlucoTouch measuring bands because they can read lower values when the blood glucose levels are higher than 22.2 mmol/L.
More information on the recall and the actions to be undertaken by the users in connection therewith can be found in the attached User Safety Information or by calling the LifeScan's User Support Department's toll free phone number 0800 5433, on workdays between 8.00 am and 4.00 pm.
This information relates only to the above mentioned lot of the medical device.
Medical Device Registration Holder in Croatia sent the safety information to the end users. This safety information can be found here (in Croatian).
