| TGA Action ID |
RC-2025-RN-00599-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITEK 2 AST GN cards. An in vitro diagnostic medical device (IVD)
Product code: AST-XN24 TEST KIT 20 CARDS
Reference number: 424351
All unexpired lots |
| ARTG Number |
196634 |
| Unique Device Identifier (UDI) |
03573026 630874 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Customers after implementing VITEK 2 AST GN cards with the updated Colistin formula (cs02n) are obtaining false resistant Colistin results primarily with multidrug resistant Acinetobacter baumannii and Pseudomonas aeruginosa. |
| Instructions for Customers/Users |
bioMérieux recommends as a short-term solution, whilst they investigate the root cause of the problem, that customers confirm any resistant colistin (cs02n) results for multidrug resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates via an alternate method for all existing and future AST cards with cs02n.
If appropriate for customers laboratory, create a custom bioART rule to show when resistant colistin (cs02n) results are obtained for Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates (refer to the VITEK 2 Software User Manual for instructions).
Based on individual facility policy, customers may wish to perform retrospective review of resistant results.
This action has been closed out on 18/02/2026 |
| Action Commencement Date |
4/07/2025 |
| Responsible Entity |
|
| Contact Information |
1800333421- bioMérieux Helpdesk |