BEUDAMED
    FDA Enforcement Class II Terminated

    Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205

    Recall: Z-2436-2018 · Reported July 25, 2018

    Enforcement

    Recall Number
    Z-2436-2018
    Event ID
    79784
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2018
    Initiation Date
    March 21, 2018
    Classification Date
    July 13, 2018
    Termination Date
    June 12, 2020
    Address
    500 Gbc Dr Ms 514, Po Box 6101, Newark, DE, 19702-2466, United States

    Description

    Dimension Vista¿ CTNI Sample Diluent, KD692, SMN# 10445205

    Reason

    The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.

    Code Info

    lot # 17171BD, UDI # (UDI) 008427680158927BDA3418060110445205

    Distribution

    The products were distributed to the following US states: 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, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The products were distributed to Guam, Saipan, and Virgin Islands. The products were distributed to the following countries: Australia, Austria, Bahamas, Belgium, Brazil, Canada, Canary Islands, Croatia, Czech Republic, Denmark, France, Germany, Italy, Japan, Lebanon, Netherlands, Poland, Portugal, Qatar, Russian Federation, Slovakia, Slovenia, Saudi Arabia, South Korea, Spain, Switzerland, and United Arab Emirates.

    Quantity

    1446