Events

Recall of Device Recall Precision Blood Glucose Test Strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories, 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
    25087
  • Event Risk Class
    Class 2
  • Event Number
    Z-0403-03
  • Event Initiated Date
    2002-11-08
  • Event Date Posted
    2002-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25134
  • 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 Oxidase, Glucose - Product Code CGA
  • Reason
    Use of glucose blood strips may provide false high results.
  • Action
    Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.

Device

Device Recall Precision Blood Glucose Test Strips

Manufacturer

Abbott Laboratories, Inc.
  • Manufacturer Address
    Abbott Laboratories, Inc., 4-A Crosby Drive, Bedford MA 01730
  • Source
    USFDA