Vitek 2 Ast-ys08 Test Kits

Recalling firm

Medi'Ray New Zealand Ltd

Product

VITEK 2 AST-YS08 test kits. [Device]. Model: VITEK 2 AST-YS08 test kits manufactured on or after 18Jul2025.

Reason

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...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-04

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/9d461717-4079-4927-9b7c-517007ccd3af