Events

Recall of Device Recall IRISpec" CA/CB twopart urine chemistry control twin 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
    62555
  • Event Risk Class
    Class 3
  • Event Number
    Z-2124-2012
  • Event Initiated Date
    2012-07-09
  • Event Date Posted
    2012-08-01
  • 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=110976
  • 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 recalled after it received complaints of irispec ca/cb two part urine chemistry control, 101131-12, where the nitrite results read negative for the part b control, which should be positive.
  • Action
    The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.

Device

Device Recall IRISpec" CA/CB twopart urine chemistry control twin set
  • Model / Serial
    Iris Diagnostics part number 800-0074, lot number 131-12.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. || Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
  • Manufacturer
    Iris Diagnostics

Manufacturer

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