Events

Recall of Device Recall BD Viper LT System

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
    70164
  • Event Risk Class
    Class 2
  • Event Number
    Z-1816-2015
  • Event Initiated Date
    2014-11-07
  • Event Date Posted
    2015-06-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132379
  • 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
    real time Nucleic acid amplification system - Product Code OOI
  • Reason
    Potential for false positive chlamydia trachomatis (ct) results and neisseria gonorrhoeae (gc) results when processing the ct qx and gc qx assays on the bd viper lt instrument.
  • Action
    BD sent an Urgent Field Corrective Action letter dated November 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were advised: a. Include the date recall was initiated, if it is already underway or the date your firm plans to start the recalling process. b. How do you plan to notify all the consignees affected by this recall? (press release, letter, telefax, telephone, e-mail, visit, etc.) The customer was initially contacted via a phone call and subsequently provided with a written communication. c. How do you plan to monitor the number of consignees non-responding to the recall communication? The single US customer was contacted by phone and provided the written communication. d. How do you plan to do effectiveness checks of this recall? The affected instrument will be corrected. e. Date your firm ceased further distribution of the product(s). Product was not placed on hold. This issue does not affect new customers. f. How do you plan to store the recall product? BD has not requested that instruments or reagents be returned. g. How do you plan to dispose of the recall products? BD is not requesting that customers return the instruments or reagents. If you require further assistance or clarification, please contact the BD Technical Services Department at 1-800 638-8663.

Device

Device Recall BD Viper LT System
  • Model / Serial
    Only the BD Viper LT Systems, catalog number 442839, that utilize the CT/GC Assays are affected. Serial numbers VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
  • Product Description
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA