Events

Recall of LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIO-RAD LABORATORIES (CANADA) LTD..

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
    22795
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-05
  • 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
    Intact pth may not meet the thawed unopened and thawed open vial stability claims as printed in the package inserts. the claims for intact pth have been revised.

Device

LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
  • Model / Serial
    Model Catalog: 366 (Lot serial: >10 CONTACT MFR); Model Catalog: 364 (Lot serial: >10 CONTACT MFR); Model Catalog: 365 (Lot serial: >10 CONTACT MFR); Model Catalog: 359X (Lot serial: 57470); Model Catalog: 359X (Lot serial: 57460); Model Catalog: 359X (Lot serial: 57450); Model Catalog: 359X (Lot serial: 57440); Model Catalog: 359X (Lot serial: 57430); Model Catalog: 359X (Lot serial: 57490); Model Catalog: 359 (Lot serial: 57431L); Model Catalog: 359 (Lot serial: 57441L); Model Catalog: 359 (Lot serial: 57451L); Model Catalog: 359 (Lot serial: 57461L); Model Catalog: 359 (Lot serial: 57471L); Model Catalog: 359 (Lot serial: 57481L); Model Catalog: 359 (Lot serial: 57491L); Model Catalog: 359X (Lot serial: 57480)
  • Product Description
    LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL;LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL FOUR LEVEL;LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL LEVEL LTA
  • Manufacturer
    BIO-RAD LABORATORIES (CANADA) LTD.

Manufacturer

BIO-RAD LABORATORIES (CANADA) LTD.