| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01342-1 |
| Product Name/Description |
VITEK 2 System
Catalogue Numbers: 413395, 413396
ARTG Number: 196634 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
There have been recent complaints that the VITEK 2 meropenem (MEM, mem02n) is overcalling resistance for isolates of Aeromonas hydrophila. False resistance was confirmed when isolates from customer sites were tested internally by broth microdilution (BMD), the reference method used for development of mem02n. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is advising their cusotomers to implement additional supression rules for the reporting of resistant results for Aeromonas species. |
| Contact Information |
1800 333 421 - Technical Assistance Department |