Events

Recall of Device Recall Randox Liquid Assayed Specific Protein Control Level 3 (SP Control 3)

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
    80211
  • Event Risk Class
    Class 2
  • Event Number
    Z-2280-2018
  • Event Initiated Date
    2018-05-22
  • Event Date Posted
    2018-06-13
  • 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=164879
  • 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
    The recalling firm has confirmed that free kappa light chains in liquid assayed specific protein controls increase over the shelf life of the product. this may lead to a delay in reporting free kappa light chains results, which are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lambda chains.
  • Action
    On May 22, 2018, Randox issued an Urgent Field Safety Notice to affected distributors along with an Important Notice and updated IFU. The letter advised customers of the product issue. It further instructed distributors to do the following: 1. Discuss the contents of the notice with your Medical Director. 2. Place a copy of the important notice and updated IFU into any remaining stock. 3. Complete and return the vigilance response section of this form to technical.services@randox.com within five working days. If you have any questions after reviewing this information, you may contact the firm at technical.services@randox.com.

Device

Device Recall Randox Liquid Assayed Specific Protein Control Level 3 (SP Control 3)
  • Model / Serial
    All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed to accounts in CA, IN, KS, ME, and WV, and PR. Foreign distribution to Australia, Bangladesh, Belarus, Belgium, Brazil, Cambodia, Canada, Chile, China, Colombia, Cyprus, Denmark, Dutch Caribbean, Ecuador, Egypt, El Salvador, Ethiopia, Falkland Islands, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Italy, Jordan, Kenya, Saudi Arabia, Korea, Kuwait, Latvia, Lebanon, Peru, Lithuania, Macedonia, Malaysia, Malta, Mauritius, Mexico, Morocco, Myanmar, New Zealand, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Oman, Thailand, Netherlands, Turkey, United Arab Emirates, United Kingdom, Ukraine, Vietnam, and Zimbabwe.
  • Product Description
    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
  • 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