Events

Recall of Device Recall BD Latitude

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    26927
  • Event Risk Class
    Class 2
  • Event Number
    Z-1221-03
  • Event Initiated Date
    2003-07-23
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28784
  • 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
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Reason
    Test strips may not be meeting specifications at the lower range of glucose values.
  • Action
    On July 23, Becton Dickinson Canada sent out a recall notification to their Canadian customers to recall the product and return to BD Canada.

Device

Device Recall BD Latitude
  • Model / Serial
    Catalog # 322002 (fifty count packaging) Lot Number: 2064256.  Catalog # 322003 (one hundred count packaging) Lot Numbers: 2064256, 2064273, 2071280.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to the Becton Dickinson Canada, Inc.,
  • Product Description
    BD Blood Glucose Test strips. BD Latitude, 100 Test Strips 100 Bandelettes Reactives, Manufactured for BD by Nova Biomedical Corp, Waltham, MA 02454, Distributed by Becton Dickinson Canada, Inc., Oakville, ON.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Drive, Franklin Lakes NJ 07417
  • Source
    USFDA