BEUDAMED
    FDA Recall Open, Classified

    VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    Recall: Z-2671-2025 · Initiated June 26, 2025

    Recall

    Recall Number
    Z-2671-2025
    Event Number
    97269
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    LON
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 26, 2025
    Posted
    September 29, 2025
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    VITEK 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export only

    Reason

    Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards

    Action

    On 06/27/2025, the firm sent an "URGENT FIELD SAFETY NOTICE" letter to customer informing them that VITEK 2 users, who are using VITEK 2 GN-AST cards with Colistin formulation, cs02n, have reported obtaining false resistant Colistin results with Acinetobacter baumannii complex and Pseudomonas aeruginosa isolates. Customers are required to: bioMrieux recommends you confirm any resistant colistin (cs02n) results for multidrug resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates via an alternate method for all existing and future AST cards with cs02n. If appropriate for your laboratory, create a custom bioART rule to show when resistant colistin (cs02n) results are obtained for Pseudomonas aeruginosa and Acinetobacter baumannii complex isolates (refer to the VITEK 2 Software User Manual for instructions). Based on individual facility policy, you may wish to perform retrospective review of resistant results. Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred the product. Complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this product correction notice does not impact your facility. For questions or further assistance, contact the local bioMerieux Customer Service Representative.

    Distribution

    International distribution in the countries of Albania, Armenia, Australia, Austria, Belgium, Bosnia, Bulgaria, China, Croatia, Cyprus, Czech Republic/Slovakia, France, Germany, Greece, Iberia, India, Israel, Italy, Japan, Lithuania, Macedonia, Malaysia/Brunei, Moldova, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Switzerland, Taiwan, Thailand, and Turkey.

    Quantity

    235269 cards