BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

    Recall: Z-0542-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0542-2026
    Event ID
    97835
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Cellavision AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2025
    Initiation Date
    October 8, 2025
    Classification Date
    November 18, 2025
    Address
    Forskningsbyn Ideon, Scheelevagen 19a, Lund, N/A, Sweden

    Description

    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.

    Reason

    Automated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic results.

    Code Info

    UDI: 0735004097202/ Serial Numbers 63220-70093 or CN63220-CN70093 Serial Numbers 60001-63219 or CN60001-CN63219

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR.

    Quantity

    688 units