Biomerieux Inc recalls VITEK 2 Gram Negative test kits containing colistin (cs01n)

Recall date

May 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2770-2017

FDA classification

Class II

Brand / firm

Biomerieux Inc

Sold / distributed

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…

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VITEK 2 Gram Negative test kits containing colistin (cs01n)