Onetouch®pro - glycaemic self-management system intended for home and ambulatory use 에 대한 현장 안전성 서한

Croatian data is current through September 2015. All of the data comes from the Agency for Medical Products and Medical Devices of Croatia, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Croatia.

The Agency for Medicinal Products and Medical Devices has been informed by the company Johnson & Johnson S.E. d.o.o. Zagber about the voluntary recall of the medical device OneTouch®Pro - glycaemic self-management system intended for home and ambulatory use, manufactured by LifeScanEurope - Division of Cilag GmbH International, Switzerland.
The manufacturer of the product OneTouch®Pro has discovered that the analyser yields incorrect results of the glucose level above 56.8 mmol/l. Certain measurements in described cases will be reduced for exactly 56.8 mmol/l, and such an incorrect result may be fatal for the patient. The glucose level above 56.8 mmol/l is an exceptionally rare occasion.
The registration holder of the medical device, Johnson & Johnson S.E. do.o. has in collaboration with the manufacturer LifeScanEurope - Division of Cilag GmbH International, Switzerland initiated a safety corrective measure recalling the product OneTouch®Pro from the market. The defective product will be replaced by an accurate one.
Hereby we inform all users to stop using the product OneTouch®Pro - glycaemic self-management system, manufactured by LifeScan Europe. We wound kindly ask our users to use other analysers not afflicted by this problem or to ask their doctor, as long as the analyser has not been replaced by an accurate one. In order to replace the defective OneTouch®Pro - glycaemic self-management system, users may contact Johnson & Johnson S.E. d.o.o./LifeScan Croatia’s customer service at 0800 5433.
No adverse event report associated with the use of OneTouch®Pro - glycaemic self-management system has been received in Croatia by now.
This recall does not refer to OneTouch® Ultra® and OneTouch® Vita® meters of glucose blood level and OneTouch® Vita® test strips. The aforementioned products may be used safely.