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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00172-1
Product Name/Description Oxoid Antimicrobial Susceptibility Testing Discs for Norfloxacin (NOR10). An in vitro diagnostic medical device (IVD)

Item Number: CT0434B
Lot Number: 1192177
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/02/2013
Responsible Entity Thermo Fisher Scientific Australia & New Zealand
Reason/Issue Investigations have confirmed that cartridges within this batch may contain individual discs that are not impregnated with antibiotic. Continued use of this lot could result in false indication of resistance to norfloxacin.
Recall Action Recall
Recall Action Instructions Thermo Fisher Scientific is requesting customers to inspect stock and remove any affected units from further use. A credit note will be issued once affected stock has been confirmed. This action has been closed-out on 12/02/2016.
Contact Information 08 8238 9081, Thermo Fisher Quality Management