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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00746-1
Product Name/Description	CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD). MiniMed Paradigm insulin infusion pumps (MMT- 512, MMT-712, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT- 523, MMT523K, MMT-723, MMT-723K, MMT-551, MMT-751, MMT-554 and MMT-754), MiniMed NGP Pumps (MMT-1510, MMT-1511, MMT-1512, MMT-1580, & MMT- 1712), MiniMed Guardian Monitor REAL-Time (CSS7100 & CSS7200) and CONTOUR NEXT test strips. All lots of control solution are affected.
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	27/08/2015
Responsible Entity	Bayer Australia Ltd
Reason/Issue	CONTOUR NEXT control solutions. In vitro diagnostic medical device (IVD) CONTOURNEXT control solutions are used with CONTOUR NEXT test strips and CONTOURNEXT family meters (CONTOUR XT/Next EZ, CONTOUR NEXT, CONTOUR NEXT Link, CONTOUR NEXT Link 2.4, CONTOUR NEXT USB), Medtronic MiniMed Paradigm insulin infusion pumps, MiniMed NGP Pumps Medtronic MiniMed Guardian Monitor REAL-Time . All lots of control solution are affected ARTG Number: 191635
Recall Action	Recall for Product Correction
Recall Action Instructions	Bayer is notifying healthcare professionals of changes to the instructions for use. The additional instructions provide detailed information on the proper handling of Contour Next controls. Bayer is also notifying health care professionals that if a CONTOUR NEXT control test result is outside of the control range, make sure to follow the instructions above, and perform another control test.
Contact Information	1800 289 312 - Customer Service