BEUDAMED
    FDA Recall Terminated

    Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586

    Recall: Z-2438-2018 · Initiated March 21, 2018

    Recall

    Recall Number
    Z-2438-2018
    Event Number
    79784
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2517506
    Product Code
    CDZ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 21, 2018
    Terminated
    June 12, 2020
    Address
    500 Gbc Dr Po Box 6101, Ms 514, Newark, DE, 19702-2466

    Description

    Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586

    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.

    Action

    Notification letters were distributed 3/21/18. The letters instructed customers to: Inspect stock, discontinue use of and discard the Dimension Vista Diluent lots listed in Table 1. Please review this letter with your Medical Director. Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product.

    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

    1195