CanadaVITEK 2 systems used for antimicrobial susceptibility testing—including models/catalogue numbers AST-N804 and AST-XN42 and VITEK 2 Compact 30 and Compact 60—are affected. BioMérieux identified increased out-of-range high quality control results for ceftazidime/avibactam (CZA02n), imipenem (IPM05n), imipenem/relebactam (IPR01n), meropenem/vaborbactam (MEV01n) and polymyxin B (PB02n) and reports of false resistance on VITEK 2 GN-AST cards when testing Enterobacterales/Enterobacteriaceae and P. aeruginosa; BioMérieux recommends confirmatory testing of resistant results for those organisms on VITEK 2 GN-AST cards for select antibiotics.
What's being recalled
Companies: BioMerieux, Inc., 100 Rodolphe Street, Durham, North Carolina, United States, 27712.
How to identify it
Affected products: VITEK 2 System; Lot or serial number: Not applicable.; Model or catalogue number: AST-N804
Affected products: VITEK 2 System; Lot or serial number: Not applicable.; Model or catalogue number: AST-XN42
Affected products: VITEK 2 Compact 30 Systems; Lot or serial number: Not applicable.; Model or catalogue number: Not applicable.
Affected products: VITEK 2 Compact 60 System; Lot or serial number: Not applicable.; Model or catalogue number: Not applicable.
The hazard
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.
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.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States