Events

Recall of Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar

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
    69091
  • Event Risk Class
    Class 2
  • Event Number
    Z-0974-2015
  • Event Initiated Date
    2014-06-06
  • Event Date Posted
    2015-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129613
  • 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
    Culture media, selective and differential - Product Code JSI
  • Reason
    A low level of surface and subsurface contamination of listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. the contamination is typically observed as 1-3 cfus per plate when present.
  • Action
    BD Diagnostic Systems sent a Field Correction Notice dated August 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to follow all surveillance requirements of their laboratory upon confirmation of Listeria monocytogenes. Laboratory staff should notify their respective state health department. Customers with questions should contact BD Technical Services at 800-638-8663. For questions regarding this recall call 410-316-4000.

Device

Device Recall TrypticaseTM Soy Agar with 5 Sheep Blood (TSA IITM) // MacConkey II Agar
  • Model / Serial
    Catalogue # 221291 with Lot #4050354,  4086399,  4099206 and 4143653; Catalogue #221261 with Lot # 4022158 4086443 4092199
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
  • Product Description
    TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar || Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
  • 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