Events

Recall of LIQUID CARDIAC CONTROL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ESBE SCIENTIFIC INDUSTRIES 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
    129530
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-27
  • 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
    Internal testing of the affected lots has shown an increased rate of degradation for myoglobin only. new targets and control ranges have therefore been assigned for the randox immunoturbidimetric method.

Device

LIQUID CARDIAC CONTROL
  • Model / Serial
    Model Catalog: CQ 5052 (Lot serial: 3990CK - 3992CK); Model Catalog: CQ 5053 (Lot serial: 3990CK - 3992CK); Model Catalog: CQ 5052 (Lot serial: 3909CK - 3913CK); Model Catalog: CQ 5053 (Lot serial: 3909CK - 3913CK); Model Catalog: CQ 5051 (Lot serial: 3990CK - 3992CK); Model Catalog: CQ 5051 (Lot serial: 3909CK - 3913CK)
  • Product Description
    LIQUID CARDIAC CONTROL;Liquid cardiac control
  • Manufacturer
    ESBE SCIENTIFIC INDUSTRIES INC.

Manufacturer

ESBE SCIENTIFIC INDUSTRIES INC.