BEUDAMED
    FDA Recall Open, Classified

    MicroScan Neg MIC 3J REF C54814

    Recall: Z-1772-2026 · Initiated June 25, 2025

    Recall

    Recall Number
    Z-1772-2026
    Event Number
    98553
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2919016
    Product Code
    LTT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 25, 2025
    Posted
    April 3, 2026
    Address
    2040 Enterprise Blvd, West Sacramento, CA, 95691-3427

    Description

    MicroScan Neg MIC 3J REF C54814

    Reason

    Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics

    Action

    On 07/15/2024, firm sent via mail/email an "URGENT MEDICAL DEVICE RECALL" Letter to customer inform them that customers have reported multiple patient samples with skipped wells for Ceftolozane/Tazobactam (C/T) when tested with MicroScan Neg MIC 3J Lot 2025-08-23. The C/T 2/4 dilution well exhibited no growth while growth was observed in the C/T 4/4 well. Customers are instructed to: "Discontinue use of this lot and discard per your laboratory guidelines. "Consider reviewing the C/T antimicrobial susceptibility test results from this lot if Enterobacterales reported as resistant and P. aeruginosa reported as intermediate or if an increasing trend in resistance has been observed for C/T in your laboratory. "The laboratory should retain the inventory of other MicroScan Neg MIC 3J lots as they are not impacted by this issue. any questions regarding this notice, please contact us: "From our website: http://www.beckmancoulter.com "By phone: please contact: Customer call center TEL :0120-566-730

    Distribution

    International distribution in the country of Japan.

    Quantity

    688 boxes (20 panels per box)