BEUDAMED
    FDA Recall Terminated

    Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021

    Recall: Z-1942-2010 · Initiated October 28, 2009

    Recall

    Recall Number
    Z-1942-2010
    Event Number
    55801
    Firm
    Inova Diagnostics Incorporated
    FEI Number
    2026994
    Product Code
    DAK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 28, 2009
    Posted
    June 30, 2010
    Terminated
    June 30, 2010
    Address
    9900 Old Grove Rd, San Diego, CA, 92131-1638

    Description

    Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021

    Reason

    The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".

    Action

    Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009. The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.

    Distribution

    Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.

    Quantity

    700 kits