Events

Recall of EPOC BGE Test Card

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

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
    50209
  • Event Risk Class
    Class 2
  • Event Number
    Z-0952-2009
  • Event Initiated Date
    2008-10-16
  • Event Date Posted
    2009-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74988
  • 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
    Ion Specific Potassium Electrode - Product Code CEM
  • Reason
    Elevated range of potassium levels.
  • Action
    The recalling firm visited the hospital on 10/18/08 to conduct an investigation. At the end of the visit, the firm representatives removed the remaining cards from the hospital and returned to the manufacturing location.

Device

EPOC BGE Test Card
  • Model / Serial
    Lot number 00260
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution --- including state of CA.
  • Product Description
    EPOC BGE Test Card || The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. || The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.
  • Manufacturer
    Epocal

Manufacturer

Epocal
  • Manufacturer Address
    Epocal, 2935 Conroy Rd, Ottawa Canada
  • Source
    USFDA