Events

Recall of Device Recall BD Affirm VPIII Microbial Identification Tests

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
    65619
  • Event Risk Class
    Class 2
  • Event Number
    Z-1812-2013
  • Event Initiated Date
    2013-06-13
  • Event Date Posted
    2013-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119730
  • 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 probe, yeast - Product Code MLA
  • Reason
    In vitro diagnostic test kit may exhibit invalid internal negative control results.
  • Action
    Becton Dickinson Diagnostic Systems notified distributors by fax on June 13, 2013, and advised consignees to discontinue use and discard affected product for credit. Distributors were requested to return their distribution list to BD for direct notification by the recaller. End users were contacted by letter on June 13, 2013 and the notification addressed to Microbiology Lab Director/Risk Managers advised that a small number of tests associated with the referenced lots of product may exhibit invalid internal negative control results. If encountered, the issue would result in an invalid test, as described in the package insert. End users were requested to discontinue use of these lot numbers, discard any remaining packages for replacement and return the enclosed response form. Customers with questions were instructed to contact BD Technical Services Department at 1-800-638-8663. For assistance regarding replacements customers were instructed to contact BD Customer Service at 1-800-675-0908. For questions regarding this recall call 410-316-4054.

Device

Device Recall BD Affirm VPIII Microbial Identification Tests
  • Model / Serial
    Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** || The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
  • 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