Events

Recall of Device Recall Lipase

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
    79767
  • Event Risk Class
    Class 2
  • Event Number
    Z-1631-2018
  • Event Initiated Date
    2018-03-02
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163324
  • 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
    Randox has now released further steps to avoid contamination of the lipase assay on rx instruments.
  • Action
    On March 1, 2018 Randox Laboratories Ltd. sent a Urgent Medical Device Correction Notification to affected customers. These customers were instructed to: 1) Update the user manual for the RX Instrument with the attached technical bulletin; 2) Replace the Instructions for Use contained within the kit with the revised version; 3) Discuss the contents of this notice with your Medical Director; 4) Complete and return the vigilance response section of this form to technical.services@randox..com within five working days; 5) Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Customer with questions may contact Randox Technical Services via e-mail technical.services@randox.com or by phone +44 (0) 28 9445 1070

Device

Device Recall Lipase
  • Model / Serial
    Lot numbers: 428000, 404175, and 404245
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of West Virginia and Puerto Rico
  • Product Description
    Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 || Product Usage: || For Professional Use for the quantitative in vitro determination of Lipase in human 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