Events

Recall of Device Recall BD Phoenix PMIC108 Panels

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
    63737
  • Event Risk Class
    Class 2
  • Event Number
    Z-0570-2013
  • Event Initiated Date
    2012-11-06
  • Event Date Posted
    2012-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114682
  • 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
    An antibiotic susceptibility test kit may produce false intermediate or false resistant results with clinically significant bacteria.
  • Action
    The firm, BD, sent an "URGENT PRODUCT RECALL" letter dated November 2012 via the telephone and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and discard any remaining packages for replacement and to complete and return the Acknowledgement Receipt Form, whether or not you have any inventory remaining, via fax to: BD Regulatory Compliance at 410-316-4258. BD will issue replacements for the discarded materials. If further assistance is needed regarding replacements please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact BD Technical Services Department at 1-800-638-8663.

Device

Device Recall BD Phoenix PMIC108 Panels
  • Model / Serial
    Lot number 2053373
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AR, CA, KY, OK, RI, WI, and WY.
  • Product Description
    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. || The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria.
  • 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