Events

Recall of IgE Calibrator Series

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
    75208
  • Event Risk Class
    Class 2
  • Event Number
    Z-0050-2017
  • Event Initiated Date
    2016-09-07
  • Event Date Posted
    2016-10-06
  • 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=149667
  • 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
    Ige, antigen, antiserum, control - Product Code DGC
  • Reason
    According to the firm, the ige calibrator series ie2492 (lot 387-392ie) value assignment has now been aligned to the 3rd international standard for human serum ige 11/234. turbidimetric (non-ifcc cal.) quality control targets and ranges now apply. the calibrator value sheet is to be updated with the new values.
  • Action
    The firm plans on contacting each consignee about the recall.

Device

IgE Calibrator Series

Manufacturer

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