Events

Recall of Device Recall epoc Blood Analysis BGEM Test Cards

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

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
    61147
  • Event Risk Class
    Class 2
  • Event Number
    Z-2034-2012
  • Event Initiated Date
    2011-06-28
  • Event Date Posted
    2012-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107399
  • 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
    Glucose oxidase, glucose - Product Code CGA
  • Reason
    Customer reported problem while performing incoming qc of newly received lot of test cards. liquid quality control results were found to be out of range. further investigation by epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.
  • Action
    Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912.

Device

Device Recall epoc Blood Analysis BGEM Test Cards
  • Model / Serial
    Catalog #CT-1004-00-00, lot number 07-11087-00
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide Distribution in the state of CA.
  • Product Description
    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System || Product Usage: Usage: || epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
  • Manufacturer
    Epocal Inc

Manufacturer

Epocal Inc
  • Manufacturer Address
    Epocal Inc, 2060 Walkley Rd, Ottawa Canada Ontario
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA