Events

Recall of BD ProbeTec¿ ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec¿ ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***

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
    30844
  • Event Risk Class
    Class 1
  • Event Number
    Z-0455-05
  • Event Initiated Date
    2005-01-10
  • Event Date Posted
    2005-02-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36692
  • 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
    An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.
  • Action
    BD notified consignees by phone on 01/10/05 and advised that users transporting patient urine samples may experience increased indeterminate results or false negative results when testing the samples on the BD ProbeTec¿ ET CT/GC Amplified DNA Assay. Subsequest to the phone notification, kit users identified as utilizing the Urine Processing Pouches were further notified by a letter. The letter describes 4 criteria contributing to the risk associated with false negative and indeterminate results. The letter advised users to discontinue use of the kits and discard for replacement. BD further advised in the notification that if the user is not utilizing the Amplification Control (AC), the firm recommends that they evaluate if urine specimens were transported and/or stored at refrigerated temperatures in the kit''s urine pouches. If specimens were transported and/or stored under the noted criteria, BD recommends that users should notify physicians who received reports of negative patient results and indicate that there is a possibility that these results were incorrect. BD plans to provide a 'Dear Physician' letter that would facilitate that notification upon request of the users.

Device

BD ProbeTec¿ ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 sto...
  • Model / Serial
    Lot/Exp 4103719 October 31, 2005 4118463 October 31, 2005 4119670 November 30, 2005 4124224 November 30, 2005 4133122 November 30, 2005 4105126 October 31, 2005 4118129 November 30, 2005 4104256 October 31, 2005 4091913 October 31, 2005 4104254 October 31, 2005 4090438 October 31, 2005 4090259 October 31, 2005 4084784 October 31, 2005 4014879 July 31, 2005 4016963 July 31, 2005 4023837 July 31, 2005 4023840 August 31, 2005 4041551 August 31, 2005 4083445 October 31, 2005 4133902 November 30, 2005
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to direct accounts in the US and to affiliated distributors internationally.
  • Product Description
    BD ProbeTec¿ ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec¿ ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***
  • 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