| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00094-1 |
| Product Name/Description |
Oxoid Antimicrobial Susceptibility Testing Discs TIM85(Timentin), CT0449B
Lot Number: 1493727 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Cartridges within the affected batch may contain some discs with a degraded or insufficient level of ingredient (clavulanic acid). A technical investigation confirmed that discs within this lot may have insufficient concentration of Ticarcillin/Clavulanic Acid potentially resulting in below specification zones of inhibition.
Continued use of this lot could result in a false indication of resistance to timentin. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are advised to inspect stock on hand and and to remove from further use all affected units. On receipt of the Reply Form ThermoFisher will issue a credit note. This action has been closed-out on 24/05/2016. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |