Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00173-1
Product Name/Description Oxoid Antimicrobial Susceptibility Testing Discs for Gentamicin (CN10). An in vitro diagnostic medical device (IVD)

Item number: CT0024B
Lot Number: 1177571
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. This could lead to a false indication of resistance to gentamicin.
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 - Oxoid Quality Assurance