Events

Recall of IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by International Remote Imaging Systems Inc.

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
    32036
  • Event Risk Class
    Class 3
  • Event Number
    Z-0884-05
  • Event Initiated Date
    2005-04-29
  • Event Date Posted
    2005-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38993
  • 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
    Nonconformance to performance specifications.
  • Action
    Firm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.

Device

IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.

Manufacturer

International Remote Imaging Systems Inc
  • Manufacturer Address
    International Remote Imaging Systems Inc, 9172 Eton Ave, Chatsworth CA 91311-5805
  • Source
    USFDA