Events

Recall of Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglob

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
    76930
  • Event Risk Class
    Class 3
  • Event Number
    Z-1876-2017
  • Event Initiated Date
    2015-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154600
  • 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, non-selective and non-differential - Product Code JSG
  • Reason
    Bd has confirmed that one lot of tsa ii and chocolate agar i-plates may fail to recover haemophilus influenzae 10211 and haemophilus parainfluenza 51505 on the chocolate agar side of the plate. all other qc organisms are correctly recovered.
  • Action
    Recall notification was initiated on March 27, 2015. US customers were contacted via letters sent by UPS. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was at their facility. The acknowledgement form included with the follow up letter that is faxed back to BD will be reconciled with the customer list. BD will contact 100% of non-respondents to verify receipt of the customer letter.

Device

Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood (TSA II) and Chocolate II Agar (GC II A...
  • Model / Serial
    Part/Cat No. 221302  Lot / Serial No. 4365741
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA
  • Product Description
    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate || Product Usage: || Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA