Events

Recall of Randox Lipase (Colorimetric)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Randox Laboratories 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
    75207
  • Event Risk Class
    Class 2
  • Event Number
    Z-0123-2017
  • Event Initiated Date
    2016-08-02
  • Event Date Posted
    2016-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149666
  • 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
    Lipase hydrolysis/glycerol kinase enzyme, triglycerides - Product Code CDT
  • Reason
    According to the firm carry over was observed when the lipase test is run directly before or after the ldl and triglycerides assays. customers are instructed to amend the running order for all instruments using these reagents to ensure lipase is not place directly before or after ldl or triglycerides. a correction was made to the ifu for the lipase assay and all customers who purchased the lipase kit in the usa were contacted with the updated instruction.
  • Action
    Randex Laboratories sent an Urgent Field Safety Notice letter dated June 17, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the response section of this form technical.services@randox.com. For questions contact Randex Technical Service.

Device

Randox Lipase (Colorimetric)
  • Model / Serial
    Catalogue number:   LI3837, LI7979, LI8050, LI8361
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Randox Lipase (Colorimetric) || Product Usage: || A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
  • Manufacturer
    Randox Laboratories Ltd.

Manufacturer

Randox Laboratories Ltd.
  • Manufacturer Address
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • Manufacturer Parent Company (2017)
    Randox Holdings Limited
  • Source
    USFDA