Recall MonitorHealth Products
VITEK® 2 Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Microbiology
Product: VITEK® 2 Systems
Issue: Medical devices - Performance
What to do: BioMérieux recommends confirmatory testing of resistant results for Enterobacterales/Enterobacteriaceae and P. aeruginosa on VITEK® 2 GN-AST cards for select antibiotics.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| VITEK 2 System | Not applicable. | AST-N804 |
| VITEK 2 System | Not applicable. | AST-XN42 |
| VITEK 2 Compact 30 Systems | Not applicable. | Not applicable. |
| VITEK 2 Compact 60 System | Not applicable. | Not applicable. |
Issue
BioMérieux identified increased out-of-range high quality control results for the following antibiotic formulations: ceftazidime/avibactam (CZA02n), imipenem (IPM05n), imipenem/relebactam (IPR01n), meropenem/vaborbactam (MEV01n), and polymyxin B (PB02n), as well as reports of false resistance on VITEK® 2 GN-AST Cards when testing Enterobacterales/Enterobacteriaceae and P. aeruginosa.