BEUDAMED
    FDA Recall Terminated

    Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA

    Recall: Z-0295-2008 · Initiated September 17, 2007

    Recall

    Recall Number
    Z-0295-2008
    Event Number
    44941
    Firm
    Nova Biomedical Corporation
    FEI Number
    1219029
    Product Code
    JBS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 17, 2007
    Posted
    January 17, 2008
    Terminated
    March 16, 2012
    Address
    200 Prospect St, Waltham, MA, 02453-3457

    Description

    Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA

    Reason

    Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples

    Action

    Nova issued a Customer Advisory Notice notification by phone on 9/17/07 to contact customers using a script . If the facility reports Normalized Ionized Calcium or Normalized Ionized Magnesium, Nova Biomedical will replace existing stock of Nova 8 calibrator packs. If the facility does not report Normalized Ionized Calcium or Normalized Ionized Magnesium, the account can continue to use the existing lot of calibrator packs.This contact will be documented within the Nova Biomedical complaint database. Intemational Customer Advisory Notice being sent to Nova Biomedical Subsidiariies and Distributors by Federal Express Envelope.The Federal Express envelopes tracking number will be used for delivery confirmation.

    Distribution

    Worldwide, USA, Canada, Argentina, Bangladesh, Bolivia, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,Germany,Greece, Hungary, India, Indonesia, Ireland,Italy, Japan, Korea, Mexico, Peru, Poland, Scotland, South Africa, Spain, Sri Lanka. Switzerland, Syria ,Taiwan, Turkey and The United Kingdom

    Quantity

    2,999 units