Events

Recall of Device Recall RX Imola

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
    79968
  • Event Risk Class
    Class 2
  • Event Number
    Z-2059-2018
  • Event Initiated Date
    2018-05-04
  • 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=164051
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    Abnormal premature termination of the software could affect the use of the analyser when running patient samples. the impact being a delay in reporting test results.
  • Action
    All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.

Device

Device Recall RX Imola
  • Model / Serial
    GTIN 05055273206104. All serial numbers.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including Puerto Rico and the state of : West Virginia.
  • Product Description
    RX Imola (RX4900) || For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
  • 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