FDAFDA · Food and drugs·Recall number Z-2770-2017
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Published August 2, 2017 · Recall initiated: May 16, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomerieux Inc
- Distributor
- 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.
- Lot
- REF # (Description): 418114 (AST-GN94), 22258 (AST-N102), 412605 (AST-N194), 412921 (AST-N199), 412862 (AST-N201), 412863 (AST-N202), 412924 (AST-N205), 412918 (AST-N210), 413061 (AST-N212), 413083 (AST-N222), 413112 (AST-N225), 413171 (AST-N236), 413172 (AST-N237), 413204 (AST-N239), 413205 (AST-N240), 413391 (AST-N242), 413394 (AST-N245), 413397 (AST-N248), 413572 (AST-N249), 413722 (AST-N253), 413724 (AST-N255), 413725 (AST-N256), 413753 (AST-N261), 414164 (AST-N272), 414286 (AST-N276), 414492 (AST-N279), 414531 (AST-N280), 414532 (AST-N281), 414972 (AST-N288), 415063 (AST-N292), 415369 (AST-N293), 415433 (AST-N295), 416005 (AST-N299), 416241 (AST-N300), 416590 (AST-N303), 416913 (AST-N308), 416914 (AST-N309), 417426 (AST-N315), 417952 (AST-N318), 418204 (AST-N320), 418489 (AST-N322), 418513 (AST-N235), 418514 (AST-N326), 418630 (AST-N328), 418631 (AST-N329), 418675 (AST-N331), 418676 (AST-N332), 418985 (AST-N335), 419077 (AST-N338), 419341 (AST-N339), 420063 (AST-N343), 420440 (AST-N344), 420867 (AST-N347), 420856 (AST-N348), 421258 (AST-N352), 421297 (AST-N353), 421350 (AST-N354), 421351 (AST-N355, 421451 (AST-N357), 421441 (AST-N358), 421583 (AST-N360), 421584 (AST-N361), 421585 (AST-N362), 421692 (AST-363), 421693 (AST-N364), 421830 (AST-N365), 421853 (AST-N366), 421854 (AST-N367), 421855 (AST-N368), 410025 (AST-XN01), 413230 (AST-XN05)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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