BEUDAMED
    FDA Recall Terminated

    Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

    Recall: Z-0943-2021 · Initiated November 18, 2020

    Recall

    Recall Number
    Z-0943-2021
    Event Number
    86926
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    DFH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 18, 2020
    Terminated
    December 23, 2024
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A

    Reason

    Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.

    Action

    On 11/30/2020, the firm emailed an "Urgent Field Safety Notice" to its U.S. Customers informing them that investigations have confirmed that the quality control (QC), high and low controls, provided with specific product and lot numbers are consistently demonstrating a ~15% positive bias compared to assigned values and customers may experience QCs consistently reporting results close to the upper acceptable limits, and QC failures may occur on the affected products. Customer are instructed: 1. Users may continue to use any remaining kits of the affected product in their stock. As per the product package insert sample results obtained should only be accepted if the control results are within +/-20% of the concentrations stated on the QC certificate provided. 2. To complete the E-Back Form TSWS18 to [email protected] or to their local representative within one week of receiving this notification. Customers are also instructed: -To pass on the notification to all those who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. -To transfer this notification to other organizations on which the information has an impact. -To maintain awareness on this notification for any appropriate period. Any questions, contact the local representative or Technical Support Group: UK technical support is: Telephone: +44(0) 1214569696 Email: [email protected] Customers in the USA may choose to instead contact the local representative at: Telephone: 800-633-4484 [email protected]

    Distribution

    U.S.: CO, FL, IA, MA, NC, NJ, NY, OH, SD, and UT. O.U.S.: Not provided

    Quantity

    213 kits in the U.S.