Events

Recall of Becton Dickinson's ProbeTec (tm) ET Instrument

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
    26884
  • Event Risk Class
    Class 1
  • Event Number
    Z-1094-03
  • Event Initiated Date
    2003-07-21
  • Event Date Posted
    2003-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28655
  • 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
    Dna-Reagents, Neisseria - Product Code LSL
  • Reason
    Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
  • Action
    The recalling firm notified consignees by letter on 7/21/2003 and advised of the potential for incorrect optical bundle installation. The firm provided an optical test procedure with materials to conduct an on site performance test. Consignees were instructed not to report patient results until optical performance has been verified. Firm will replace or repair failing instruments.

Device

Becton Dickinson's ProbeTec (tm) ET Instrument
  • Model / Serial
    Instrument serial numbers 1001-2056
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to domestic and military end users nationwide and international distributors.
  • Product Description
    Becton Dickinson's ProbeTec (tm) ET Instrument
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Circle, Sparks MD 21152
  • Source
    USFDA