| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01185-1 |
| Product Name/Description |
Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin, CT1644B
Lot Number: 1675622
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal investigation has confirmed that Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin / Dalfopristin may contain a small number of discs that produce variable results. Not all of the lot is affected, however, it has been identified that some discs may produce larger than expected or unexpected zones of inhibition.
Continued use of this lot could result in quality control failures, delayed results or false susceptibility reporting. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine the affected units. Results issued with the above batch should be reviewed against case histories, other results and other relevant individual data.
This action has been closed on the 17/09/2018 |
| Contact Information |
(08) 8238 9044 - Thermo Fisher Scientific |