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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