Events

Recall of ARIES System

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

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
    77052
  • Event Risk Class
    Class 2
  • Event Number
    Z-2094-2017
  • Event Initiated Date
    2017-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154884
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • Reason
    The hand-held barcode scanner that is used as an accessory to enter aries cassette and specimen identifications on the aries systems populates patient sample ids with a previously scanned sample id when entering orders into an aries instrument.
  • Action
    A recall notification letter was sent out on April 19, 2017. Prior to the recall letter being sent, the recalling firm sent a Customer Advisory Notification on April 14, 2017. The firm is also adding an accountability form to the customer notifications in order to document the customer responses to ensure that we account for the estimated 15 distributed units. For further questions, please call (877) 785-2323.

Device

ARIES System
  • Model / Serial
    ARIES System UDI: 00840487101537 and ARIES M1 System UDI: 00840487100080
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of Finland and China.
  • Product Description
    ARIES System and ARIES M1 System
  • Manufacturer
    Luminex Corporation

Manufacturer

Luminex Corporation
  • Manufacturer Address
    Luminex Corporation, 12212 Technology Blvd, Austin TX 78727-6101
  • Manufacturer Parent Company (2017)
    Luminex Corporation
  • Source
    USFDA