Events

Recall of Device Recall AccuData GTS

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
    35022
  • Event Risk Class
    Class 2
  • Event Number
    Z-1366-06
  • Event Initiated Date
    2006-06-22
  • Event Date Posted
    2006-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46545
  • 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
    Blood Glucose Meter - Product Code CGA
  • Reason
    The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip.
  • Action
    A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.

Device

Device Recall AccuData GTS
  • Model / Serial
    All units.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.
  • Product Description
    AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS Plus with Accu-Chek Advantage blood glucose meter, Cat no. 3000249 and/or GTS with Accu-Chek Advantage blood glucose meter, Cat. no. 404, and/or Replacement GTS with Accu-Chek Advantage blood gulcose meter, Cat. no. 404R, and/or Replacement Base Unit with Advantage Module, Cat. no. 3426050. Ref. nos. 030002490001 and 03136833001 both have meters with model no. 777.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA