Class 2 Device Recall VITEK 2 Gram Negative test kit containing colistin (cs01n)

• Date Initiated by Firm: May 16, 2017
• Date Posted: June 27, 2017
• Recall Status: Terminated on June 19, 2019
• Recall Number: Z-2770-2017
• Recall Event ID: 77373
• Product Classification: Phenotypic test kit, non-susceptible/elevated MIC organisms, cultured isolates - Product Code PTJ
• Product: VITEK 2 Gram Negative test kits containing colistin (cs01n)
• Code Information: 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)
• FEI Number: 1950204
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: 314-731-8694
• Manufacturer Reason for Recall: 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 Determined Cause: Other
• Action: Customers were notified on or about 05/16/2017 and then notified again with an updated letter. Instructions to customers included requesting that the attached acknowledgement form be completed, distribute the recall notification to customers, and provide the notice to future customers.
• Quantity in Commerce: 1,520,000 cards
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.