| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00291-1 |
| Product Name/Description |
OXOID AST DISC CT1412B – Cefpirome CPO30ug 5x 50 discs. An in vitro diagnostic medical device.
Lot Numbers:1611705, 1693625
ARTG Number: 208273
Thermo Fisher Scientific Australia & New Zealand - Antimicrobial susceptibility testing IVDs |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that the performance of antibiotic in ThermoScientific Oxoid CT1412B CPO30 Cefpirome may decrease when stored over 2°C after 24 months. The product has a registered shelf life of 36 months.
Performance remains unaffected throughout shelf life when stored at -20°C to +2°C. Continued use of lots older than 24 months if stored at 2-8°C, could result in false resistance reporting for Cefpirome. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising customers to inspect stock for affected product and remove them from further use. Users should destroy/discard all current and unused stock of the affected batches.
This action has been closed out on the 16/10/2018. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |