Events

Recall of On-Site Alcohol IVD || A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. || Catalog numbers: || 47464 Roche Diagnostics Label || A305-02 Varian, Inc. label

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Varian, 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
    26829
  • Event Risk Class
    Class 3
  • Event Number
    Z-1202-03
  • Event Initiated Date
    2003-07-18
  • Event Date Posted
    2003-09-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28524
  • 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
    Nad-Nadh, Specific Reagent For Alcohol Enzyme Method - Product Code DML
  • Reason
    Stability in question.
  • Action
    Recall letter was sent on July 18, 2003 which instructs to stop using affected product and return it for free replacement.

Device

On-Site Alcohol IVD || A single use enzymatic assay for qualitative detection of alcohol in urine...
  • Model / Serial
    None given.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    On-Site Alcohol IVD || A single use enzymatic assay for qualitative detection of alcohol in urine or saliva. || Catalog numbers: || 47464 Roche Diagnostics Label || A305-02 Varian, Inc. label
  • Manufacturer
    Varian, Inc.

Manufacturer

Varian, Inc.
  • Manufacturer Address
    Varian, Inc., 25200 Commercentre Drive, Lake Forest CA 92630-8810
  • Source
    USFDA