| TGA Action ID |
RC-2026-RN-00015-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
VITEK 2 AST-XN24. An in vitro diagnostic medical device (IVD).
Reference: 424351
Drug Impacted: cza02n/ipr01n/mev01n |
| ARTG Number |
196634 |
| Unique Device Identifier (UDI) |
N/A |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
BioMérieux has identified an increase in complaints for out-of-range high (OORH) quality control (QC) results for the following antibiotic formulations:
• Ceftazidime/Avibactam (cza02n)
• Meropenem/Vaborbactam (mev01n)
• Imipenem/Relebactam (ipr01n)
A small number of VITEK 2 GN-AST cards users have also reported false resistant antibiotic results with the same antibiotics when testing strains of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa.
Please note that the internal investigation is still ongoing, and the root cause has not yet been fully determined.
There are two potential impacts: QC failure and/or false resistant results of patient isolates due to overcalling of the MIC value. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient’s health. |
| Instructions for Customers/Users |
Customers with clinically significant isolates of Enterobacterales species and Pseudomonas aeruginosa with resistant results to Ceftazidime/Avibactam (cza02n), Imipenem/Relebactam (ipr01n) or Meropenem/Vaborbactam (mev01n) are advised to consider using an alternative method to confirm results. The determination of clinical significance should be made by each laboratory based on the antimicrobial susceptibility profile and the local availability of alternative antibiotics.
Customers can set up a custom bioART rule to trigger when resistant results are obtained for the impacted bug drug combinations. |
| Action Commencement Date |
9/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 333 421 - Biomerieux Australia |