Events

Recall of Iris Diagnostics Division iQ Control/Focus Set

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

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
    64910
  • Event Risk Class
    Class 2
  • Event Number
    Z-1328-2013
  • Event Initiated Date
    2012-09-18
  • Event Date Posted
    2013-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117370
  • 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
    Urinalysis controls (assayed and unassayed) - Product Code JJW
  • Reason
    The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. this results in the instrument not passing controls and the customer not being able to run patient samples.
  • Action
    IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics.

Device

Iris Diagnostics Division iQ Control/Focus Set
  • Model / Serial
    Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
  • Product Description
    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. || Product Usage: For in vitro diagnostic use with the iQ200 series.
  • Manufacturer
    Iris Diagnostics

Manufacturer

Iris Diagnostics
  • Manufacturer Address
    Iris Diagnostics, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA