Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36608 |
| Brand Name: | VITEK 2 AST-YS08 test kits |
| Model: | VITEK 2 AST-YS08 test kits manufactured on or after 18Jul2025. |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux Inc |
| Issue: | Manufacturing Quality Control (QC) failures were observed during release testing for VITEK 2 AST-YS08 test kits manufactured on or after 18Jul2025. Quality Control MIC results for Amphotericin B were out-of-range-high (OORH). To be noted, there are no S/I/R interpretations for Amphotericn B. The antibiotic is reported as MIC only. If/When using AST-YS08 test kits manufactured on or after 18Jul2025, implement a VITEK 2 Systems BIOART rule to suppress analysis of the Amphotericin B antibiotic, and perform Amphotericin B testing via an alternate method if treatment with Amphotericin B is considered for the patient. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 4/3/2026 |
