Events

Recall of Magnesium on RX Imola analyser

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Randox Laboratories, Limited.

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
    75263
  • Event Risk Class
    Class 2
  • Event Number
    Z-0725-2017
  • Event Initiated Date
    2016-04-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149845
  • 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
    Photometric method, magnesium - Product Code JGJ
  • Reason
    According to the firm, carry over was observed when the amylase or pancreatic amylase test is run directly before or after the magnesium assay. an update is required to the rx imola analyser running order and an acid wash recommended when setting up the magnesium assay. a correction was made to the ifu for the magnesium assay and all rx imola customers in the usa were contacted with the updated instruction.
  • Action
    Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to technicalservikces@randox.com.

Device

Magnesium on RX Imola analyser

Manufacturer

Randox Laboratories, Limited
  • Manufacturer Address
    Randox Laboratories, Limited, Ardmore 55 The Diamond Road, Crumlin United Kingdom
  • Manufacturer Parent Company (2017)
    Randox Holdings Limited
  • Source
    USFDA