BEUDAMED
    FDA Recall Terminated

    Digital RID Plate Reader and Software Product Code: AD400

    Recall: Z-1055-2017 · Initiated October 9, 2012

    Recall

    Recall Number
    Z-1055-2017
    Event Number
    76043
    Firm
    The Binding Site Group, Ltd.
    FEI Number
    3002808340
    Product Code
    JZQ
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    October 9, 2012
    Posted
    January 19, 2017
    Terminated
    April 4, 2017
    Address
    8 Calthorpe Road, Birmingham United Kingdom

    Description

    Digital RID Plate Reader and Software Product Code: AD400

    Reason

    If a control ring is marked after reading, the software will not flag results that are out of the specified QC range.

    Action

    On 10/2012 notification letter was sent to customers requesting they take the following actions: 1. If have not already installed software version Vl.0.3 then please continue to work with version V1.0.2 until the above issues are resolved. 2. If have already installed software version V1.0.3, when processing results always mark the controlprior to reading the ring. 3. If are uncertain about the validity of any assays you have performed using software version Vl.0.3 please review the controlresults obtained and compare them to the specified control range for the RID assay and; " If the control results are acceptable then your assay is valid and results will be unaffected. " If the control results are not acceptable your assay should be considered invalid and your patient results should be reviewed and repeated as appropriate. On 02/2013 a second notification was sent in which customers were informed the new software was released. Customers were asked to take the following actions; 1. Upon receipt install the new software and uninstall the previou version 2. Install following the onscreen instructions. The installation process has not changed from previous versions. The instruction guide received with the RID Plate reader is still the current version. 3. After receipt of the new software disc complete and return the Eback form to The Binding Site. For further assistance contact Technical Services at The Binding Site via the email address: [email protected].

    Distribution

    U.S. distribution to the following; MA, GA, NY, IA, CA, IL, UT, NJ, NC, MD, MN. Foreign distribution to the following; UK, Germany, Spain, France.