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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01121-1
Product Name/Description	AxSYM Valproic Acid Reagent (An in vitro diagnostic medical device IVD) List Number: 7A71.20 Lot Number: 18439M503 ARTG Number: 13401
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	1/11/2013
Responsible Entity	Abbott Australasia Pty Ltd Diagnostic Division
Reason/Issue	Abbott has confirmed that some kits of AxSYM Valproic Acid Reagent lot 18439M503 have the potential to generate invalid calibration, control or sample runs due to Net Intensity Too Low, resulting in AxSYM instrument Error Code 1072. When a valid calibration and/or control/sample run is obtained, patient results generated with reagent lot 18439M503 are acceptable.
Recall Action	Recall
Recall Action Instructions	Abbott is providing replacement stock for users. Once replacement stock has been received, destroy any remaining units of the affected stock. Abbott is advising that if a valid calibration and/or control/sample run is obtained, patient results are acceptable.
Contact Information	1800 816 696 - Abbott Diagnostics Customer Support