Vitek® 2 Ast-xn24
- Recalling firm
- Medi'Ray New Zealand Ltd
- Product
- VITEK® 2 AST-XN24. [Device]. Model: Reference number - 424351. Affected: Drug impacted: cza02n/ipr01n/mev01n, cza02n/ipr01n/mev01n
- Reason
- The manufacturer has identified an increase in complaints for out-of-range high (OORH) quality control (QC) results for the following antibiotic formulations: Ceftazidime/Avibactam (cza02n), Imipenem/Relebactam (ipr01n), and Meropenem/Vaborbactam (mev01n). During the investigation, we identified that 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-09-25
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/3ccbfcb9-b60c-4d98-bff7-94cb8e1c07dc