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 |
|
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 |