BEUDAMED
    FDA Recall Terminated

    FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

    Recall: Z-2030-2021 · Initiated May 20, 2021

    Recall

    Recall Number
    Z-2030-2021
    Event Number
    88064
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    DFH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 20, 2021
    Terminated
    February 4, 2025
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096

    Reason

    The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

    Action

    Between the dates of 5/20-21/2021, The Binding Site (TBS) issued a "Urgent Medical device Correction" via email to affected consignees. In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1, TBS have completed reassignment of the controls; updated target values and assigned acceptance ranges are provided in Table 2. Users may continue to use remaining kits with the following revised assigned control values. 2. Please return you completed TSWS18 E-Back Form (attached) to [email protected] or to your local Binding Site representative within 5 working days of receiving this notification. Transmission of this Important information: 3. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4. Please transfer this notice to other organizations on which this action has an impact. 5. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, United Kingdom, Argentina, Egypt, GUADELOUPE, HONG KONG, India, Iran, Israel, Korea, Lebanon, Malaysia, Morocco, Oman, Singapore, Taiwan, Tunisia, Vietnam.