VITEK 2 Gram Negative test kits containing colistin (cs01n)

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• VITEK 2 Gram Negative test kits containing colistin (cs01n)

Lot codes and dates

• 71 of 71 codes

  • 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)

  Show all 71 codes

Amount recalled

1,520,000 cards

Where it was sold

• NC

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).

This product could cause temporary or reversible health problems — stop using it.