Events

Recall of Immunoassay Premium Controls

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

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
    79076
  • Event Risk Class
    Class 3
  • Event Number
    Z-0969-2018
  • Event Initiated Date
    2017-08-11
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161282
  • 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 acth in immunoassay premium and premium plus quality control does not meet the quoted reconstituted stability claim in the product ifu.
  • Action
    On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to technical.services@randox.com

Device

Immunoassay Premium Controls
  • Model / Serial
    Catalog numbers:  IA2633 (Lots: 398703, 402366) IA2638 (Lot 1666EC) IA2639 (Lots: 1486EC, 1516EC, 1626EC) IA2640 (Lots 1517EC, 1668EC)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide.
  • Product Description
    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
  • Manufacturer
    Randox Laboratories

Manufacturer

Randox Laboratories
  • Manufacturer Address
    Randox Laboratories, 515 Industrial Blvd, Kearneysville WV 25430-2778
  • Manufacturer Parent Company (2017)
    Randox Holdings Limited
  • Source
    USFDA