Events

Recall of Liquid Urine 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.

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
    77152
  • Event Risk Class
    Class 3
  • Event Number
    Z-2167-2017
  • Event Initiated Date
    2017-04-27
  • Event Date Posted
    2017-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155040
  • 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
    According to randox laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of total protein (urine). the values for the mean of all instruments are incorrect by a factor of 10. instrument specific values are correct. this does not affect the performance or stability claims of the product. as control results will be outside of the quoted range this may result in a delay in reporting the sample test results. however as the correct instrument specific means are also included in the value sheet this delay is unlikely. customers have been referred to their medical director for further advice.
  • Action
    Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890.

Device

Liquid Urine Control Level 3
  • Model / Serial
    Catalogue number UC5075 Batch number 907UC
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq
  • Product Description
    Liquid Urine Control Level 3 || For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
  • 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