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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00323-1
Product Name/Description	Oxoid Nitrocefin (+ Reconstitution Fluid) Product number: SR0112C Lot number: 1717357 ARTG number: 235687 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/03/2016
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has identified that individual bottles of Oxoid Nitrocefin (+ Reconstitution Fluid), may produce weak beta-lactamase reactions. Not all of the lot is affected; however, continued use may result in delayed or false negative reporting.
Recall Action	Recall
Recall Action Instructions	Thermo Fisher is advising users to inspect stock and remove the affected lot from use. A review of previously generated results is at the discretion of the Laboratory Director. This action has been closed-out on 02/02/2017.
Contact Information	(0)8 8238 9044