FDA-Device2017-08-02Class II
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Biomerieux Inc
Hazard
The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).
Sold states
Domestic: NC. Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.
Affected count
1,520,000 cards
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2770-2017Don't want to check this manually?
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