FDA-Device2019-02-27Class II

VITEK 2 AST-N351 Test Kit

bioMerieux, Inc.
Hazard

False Positive ESBL Phenotype

Sold states
UK and Ireland
Affected count
30,292 cartons (20 cards per carton)
Manufactured in
100 Rodolphe St, Durham, NC, United States
Products
VITEK 2 AST-N351 Test Kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0847-2019

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