Events

Recall of Device Recall Directigen (TM) EZ RSV

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

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
    27995
  • Event Risk Class
    Class 3
  • Event Number
    Z-0373-04
  • Event Initiated Date
    2003-12-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30939
  • 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
    Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus - Product Code GQG
  • Reason
    Diagnostic test kit may exhibit false positive results.
  • Action
    The recalling firm notified consignees by fax, e-mail and letters 12/15/03. The letter advised of the false positive test results and requested end users to discontinue use and discard remaining packages for replacement. Consignees were requested to return response form.

Device

Device Recall Directigen (TM) EZ RSV
  • Model / Serial
    lots 3253709, exp 12/18/03 and 3289760, exp 2/20/04
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was sold to 242 direct account end users nationwide and 2 affiliated distributors in foreign countries.
  • Product Description
    Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA