Events

Recall of Liquid Cardiac Quality Control Level 3

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
    79035
  • Event Risk Class
    Class 2
  • Event Number
    Z-0937-2018
  • Event Initiated Date
    2017-08-08
  • 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=161217
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    Randox has confirmed that troponin t and troponin i in liquid cardiac quality control cq5053 lot 4069ck does not meet the shelf-life claim in the product labelling. as the control may now fall outside the provided control ranges the product is to be recalled from the field.
  • Action
    A recall notice was issued to customers on August 1, 2017 instructing them to discontinue use of product, discard remaining product for reimbursement and provide documentation of destruction.

Device

Liquid Cardiac Quality Control Level 3

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