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
    27334
  • Event Risk Class
    Class 2
  • Event Number
    Z-0060-04
  • Event Initiated Date
    2003-09-22
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29699
  • 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
    Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
  • Reason
    Degradation of the magnesium sensor could result in low ionozed magnesium patient samples.
  • Action
    Nova Biomedical contacted customers by telephone beginning on 9/26/03. Each account was faxed or mailed Customer Information Bulletin requesting the discard of Mg++ sensors in inventory that are greater than 4 months old from date of manufacture. Replacement product will be issued.

Device

Nova Biomedical
  • Model / Serial
    Lot Number Exp. Date  304716 2/29/04  304074 2/29/04  303798 1/31/04  303515 1/31/04  303479 1/31/04  303222 1/31/04  302808 12/31/03  302652 12/31/03  302267 12/31/03  301844 11/30/03  301443 11/30/03  301219 11/30/03  212490 10/31/03  212332 10/31/03  212043 10/31/03  211170 9/30/03
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natinwide Foreign: Italy, Czech, Japan, Taiwan, Hungary, India, Israel, Mexico, Canada, Germany,Switzerland, Tunisia, Korea, Brazil, Greece, Coatia, China, France, Turkey, Thailand, Argentina. Government: VA Decator, GA
  • Product Description
    Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) || Part # 20394
  • Manufacturer
    Nova Biomedical Corporation

Manufacturer

Nova Biomedical Corporation
  • Manufacturer Address
    Nova Biomedical Corporation, 200 Prospect Street, Waltham MA 02454
  • Source
    USFDA