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Biomerieux Inc recalls VITEK 2 Gram Negative test kits containing colistin (cs01n)
Recalled August 2, 2017 · FDA recall Z-2770-2017 · Biomerieux
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). · FDA Class II
Units
1,520,000 cards
Sold at
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.
Description
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).
Product
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →