FDA-Device2025-10-08Class II
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
bioMerieux, Inc.
Hazard
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Sold states
International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.
Affected count
235269 cards
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2671-2025Don't want to check this manually?
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