Health product recall

VITEK® 2 Systems

Brand(s)
Last updated

Summary

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

Affected 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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
BioMerieux, Inc.
100 Rodolphe Street, Durham, North Carolina, United States, 27712
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-81506

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