BEUDAMED
    FDA Recall Terminated

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    Recall: Z-0043-2013 · Initiated August 10, 2012

    Recall

    Recall Number
    Z-0043-2013
    Event Number
    62968
    Firm
    Immunodiagnostics Systems Ltd 10 Didcot Way Bolden Business Park Boldon Tyne & Wear United Kingdom
    FEI Number
    3002485711
    Product Code
    NEO
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    August 10, 2012
    Posted
    October 10, 2012
    Terminated
    December 17, 2012

    Description

    IDS-iSYS N-Mid Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

    Reason

    It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.

    Action

    Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately. 2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return. 3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office. Contact information was also provided. For questions regarding this recall call +44 (191) 5195212.

    Distribution

    Nationwide Distribution including NY, CA, ME and CT.

    Quantity

    5