BEUDAMED
    FDA Recall Open, Classified

    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

    Recall: Z-0981-2022 · Initiated February 18, 2022

    Recall

    Recall Number
    Z-0981-2022
    Event Number
    89831
    Firm
    DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada
    FEI Number
    3003742580
    Product Code
    OYJ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 18, 2022

    Description

    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025

    Reason

    Evaporation of stabilizing liquid reducing shelf life.

    Action

    Notification emailed to customers 2/18/2022. The shelf-life "Collect sample by/Use by" date found on the collection device tube label has been reduced by 12 months. Contact firm if unable to recover the minimum input volume required for sample extraction. Submit online acknowledgement form and contact your DNA Genotek Account manager or Technical Services with questions: [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WI and the countries of Australia Belgium, Brazil, Canada, Chile, China, Croatia Denmark, Finland, Germany, Great Britain, Italy, Japan, Netherlands, South Africa, and Thailand.

    Quantity

    2,375,514 (US: 2,148,222 OUS: 227,292)