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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00269-1
Product Name/Description	Oxoid Antimicrobial Susceptibility Testing discs for Ertapenem (ETP10). An in vitro diagnostic medical device (IVD). Product Code: CT1761B Lot Number: 1227786
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/03/2013
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	Investigations have confirmed that cartridges within this batch may contain individual discs with insufficient amount of antibiotic. Continued use of this lot could result in false indication of resistance to ertapenem.
Recall Action	Recall
Recall Action Instructions	End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director.
Contact Information	08 8238 9044 - Oxoid Regulatory Affairs