Events

Recall of Stat Profile Critical Care PLUS (CCX) Analyzer || Catalog Number: 37413

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
    34522
  • Event Risk Class
    Class 3
  • Event Number
    Z-0577-06
  • Event Initiated Date
    2006-01-27
  • Event Date Posted
    2006-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44010
  • 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
    Analyzers may fail to perform scheduled automatic two-point calibrations and quality control runs.
  • Action
    Nova Biomedical Issued on 1/27/2006 an Advisory Notice to Stat Profile CCX Customers to report the malfunction and request the Good Laboratory Practices (GLP) be used and review be made to assure the calibration status and QC is being performed. A new software version is scheduled to be released to correct the error.

Device

Stat Profile Critical Care PLUS (CCX) Analyzer || Catalog Number: 37413
  • Model / Serial
    All S/N''s
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI
  • Product Description
    Stat Profile Critical Care PLUS (CCX) Analyzer || Catalog Number: 37413
  • 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