Events

Recall of OPTI R BLOOD GAS ANALYZER - INSTRUMENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHOENIX AIRMID BIOMEDICAL CORP..

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
    138457
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-23
  • 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
    Opti medical investigated a report from the field where an opti cca-ts2 was found to measure thb high in whole blood. internal investigation has reproduced this finding showing a positive bias in thb results in whole blood when saturated oxygen (so2) is low. this issue was found on all opti blood gas analyzers manufactured after july 2009.

Device

OPTI R BLOOD GAS ANALYZER - INSTRUMENT
  • Model / Serial
    Model Catalog: GD7031 (Lot serial: 1334 and higher); Model Catalog: GD7013 (Lot serial: 2700 and higher); Model Catalog: GD7045 (Lot serial: GD7045 - 8056 and higher); Model Catalog: GD7046 (Lot serial: GD7045 - 8056 and higher); Model Catalog: GD7046 (Lot serial: GD7046 - All); Model Catalog: GD7045 (Lot serial: GD7046 - All)
  • Product Description
    OPTI R ANALYZER
  • Manufacturer
    PHOENIX AIRMID BIOMEDICAL CORP.

Manufacturer

PHOENIX AIRMID BIOMEDICAL CORP.