| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00393-1 |
| Product Name/Description |
Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD).
Product Code: CT0449B
All lots affected
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Internal investigations by Oxoid Limited have identified variability in concentration of certain lots of Timetin TIM85. Active compound degradation over the shelf life may result in lower than specified concentration leading to Out Of Specification performance results (small zone size).
Continued use of this product could result in delayed or false resistance reporting. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher Scientific is advising users to inspect stock and remove any remaining stocks of the affected product from use. Please complete the reply form and return in order for a credit note to be issued.
Action closed out on 21/08/2018 |
| Contact Information |
08 8238 9044 - Oxoid Austalia |