BEUDAMED
    FDA Recall Terminated

    Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454

    Recall: Z-0726-2008 · Initiated November 2, 2007

    Recall

    Recall Number
    Z-0726-2008
    Event Number
    45815
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    CGL
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 2, 2007
    Posted
    February 16, 2008
    Terminated
    December 9, 2008
    Address
    200 Prospect St, Waltham, MA, 02453

    Description

    Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454

    Reason

    Incorrect Results - Creatinine results were lower than the laboratory reference method.

    Action

    Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at [email protected].

    Distribution

    Nationwide Distribution, including the state of NY

    Quantity

    286 units