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 |
|
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 |