| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01078-1 |
| Product Name/Description |
Oxoid Anti-microbial Susceptibility Testing Disc CT0024B Gentamicin (CN 10) 5x50 discs
Lot Number: 1686823
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Some discs in the affected lot may have insufficient concentration of antibiotic. This could result in an incorrect test reading due to small or absent zones of inhibition. Continued use of this lot could result in quality control failures, delayed results or false resistance reporting. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 06/06/2016. |
| Contact Information |
(08) 8238 9044 - Thermo Fisher Scientific |