BEUDAMED
    FDA Recall Terminated

    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.

    Recall: Z-0280-2012 · Initiated September 26, 2011

    Recall

    Recall Number
    Z-0280-2012
    Event Number
    60219
    Firm
    Inova Diagnostics Incorporated
    FEI Number
    2026994
    Product Code
    DHN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 26, 2011
    Posted
    November 23, 2011
    Terminated
    April 4, 2012
    Address
    9900 Old Grove Rd, San Diego, CA, 92131-1638

    Description

    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.

    Reason

    The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with the 0.5mL fill volume.

    Action

    On 9/26/11, Inova Diagnostics forwarded an Urgent Advisory Notice and Product Advisory Notice Fax Back Form to all their customers who purchased the Nova Lite Ana KSL, Product Code: 708390. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to complete the attached fax back form indicating how many of these kits they have in their inventory, quantity destroyed, method of destruction and the quantity of kits that need to be replaced. Customers were also instructed to notify their customers of the advisory notice. Customers were instructed to contact Tana Keivens with any questions or comments at (858) 586-9900 ext 351.

    Distribution

    Worldwide distribution to: USA, Mexico, Kuwait, Uraguay, Romania, Italy, Philippines, India, Malaysia, Algeria, Czechoslovakia, Brazil, Colombia, Ireland, Korea, and Saudi Arabia.

    Quantity

    500 kits