| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00516-1 |
| Product Name/Description |
CEFOTAXIME CT 256 WW F100. An in vitro diagnostic medical device (IVD)
Serial Number: 1002774320
ARTG Number: 187139 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal investigation identified a performance deviation associated with Quality Control testing of retained product samples. The QC results were out of range resulting in false resistant strains. |
| Recall Action |
Recall |
| Recall Action Instructions |
BioMerieux is requesting their customers to discontinue using and discard any remaining inventory of Etest CEFOTAXIME CT 256. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 333 421 - Technical Assistance |