Events

Recall of Device Recall AccuChek

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
    25542
  • Event Risk Class
    Class 2
  • Event Number
    Z-0715-03
  • Event Initiated Date
    2003-02-12
  • Event Date Posted
    2003-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26006
  • 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
    Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.
  • Action
    Urgent Product Correction letters dated 2/12/03 were issued to pharmacists, specific health care providers, and the laboratory manager at customer accounts. Letter recipients were asked to advise their patients to inspect their vial for a crack prior to each use.

Device

Device Recall AccuChek
  • Model / Serial
    All lots.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand.
  • Product Description
    Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and 04535120001 (All sold outside of the United States).
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

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