Events

Recall of Device Recall AccuChek Aviva

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

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
    33862
  • Event Risk Class
    Class 2
  • Event Number
    Z-0421-06
  • Event Initiated Date
    2005-11-09
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42787
  • 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
    Glucose Dehydrogenase, Glucose - Product Code LFR
  • Reason
    Incorrect patient blood glucose test results may be reported due to a software problem.
  • Action
    Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06.

Device

Device Recall AccuChek Aviva
  • Model / Serial
    Aviva meter serial numbers 52500000000 through 52510999999.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
  • Product Description
    Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed within the U.S.)
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA