Events

Recall of Nova Biomedical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nova Biomedical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    44941
  • Event Risk Class
    Class 3
  • Event Number
    Z-0295-2008
  • Event Initiated Date
    2007-09-17
  • Event Date Posted
    2008-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64558
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Sodium Test System calibrator - Product Code JBS
  • 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.

Device

Nova Biomedical
  • Model / Serial
    Lot Numbers: 610633, 701034, 704053, 707222
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
  • Product Description
    Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • Manufacturer Address
    Nova Biomedical Corporation, 200 Prospect St, Waltham MA 02453-3457
  • Manufacturer Parent Company (2017)
    Nova Biomedical Corporation
  • Source
    USFDA