Events

Recall of Device Recall BD Phoenix" Panel NMIC/ID123, Catalog 448723,

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
    58066
  • Event Risk Class
    Class 2
  • Event Number
    Z-1847-2011
  • Event Initiated Date
    2011-02-28
  • Event Date Posted
    2011-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98199
  • 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
    System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
  • Reason
    In vitro diagnostic test kit is defective and may cause false positive or false negative results.
  • Action
    BD Diagnostics Systems sent an Urgent Product Recall letter dated February 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinsue use of the affected product and discard any remaining packages. BD would issue replacements for the discarded material. Customers were instructed to complete the attached form whether or not they had any inventory remaining so that the firm may acknowledge receipt of this notification. Complete and fax the form to BD Regulatory Compliance to 410-316-4258. For further assistance contact BD Customer Service at 1-800-675-0908. For other inquiries, contact BD Technical Services at 1-800-638-8663.

Device

Device Recall BD Phoenix" Panel NMIC/ID123, Catalog 448723,
  • Model / Serial
    Lot 0223498 exp 8/31/2011
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, FL, GA, MA, MD, NC, NY, PA, TX, WA, WI, and WY and the countries of The product was distributed to medical facilities nationwide and to foreign consignees in Argentina, Brazil, Chile, and Mexico.
  • Product Description
    BD Phoenix" Panel NMIC/ID-123, Catalog # 448723, packaged 25 panels/carton, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663*** || The BD Phoenix¿ Automated Microbiology System is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The Phoenix system provides results for most aerobic and facultative anaerobic Gram negative bacteria of human origin with the use of the NMIC/ID-123 panel type.
  • 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