Events

Recall of EPOC BLOOD ANALYSIS SYSTEM - SINGLE USE BLOOD GAS ELECTROLYTE AND METABOLITE TEST CARD

According to Health Canada (via FOI), this recall involved a device in Canada 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
    26635
  • Event Risk Class
    III
  • Event Initiated Date
    2013-03-28
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Some lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end range of the glucose test sensor (>400 mg/dl). specifically after a period of storage of three (3) to four (4) months the glucose sensor may report low results at the high end of the measurement range. **note: canadian distributed product was for demonstration only**.

Device

EPOC BLOOD ANALYSIS SYSTEM - SINGLE USE BLOOD GAS ELECTROLYTE AND METABOLITE TEST CARD
  • Model / Serial
    Model Catalog: CT-1004-00-00 (Lot serial: 07-12283-00 to 07-13017-00)
  • Product Description
    epoc BGEM Test Card
  • Manufacturer
    EPOCAL INC.

Manufacturer

EPOCAL INC.
  • Manufacturer Address
    OTTAWA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC