Events

Recall of Device Recall BD Bioscience Trucount Absolute Counting Tubes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton, Dickinson and Company, BD Biosciences.

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
    73748
  • Event Risk Class
    Class 2
  • Event Number
    Z-1570-2016
  • Event Initiated Date
    2016-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144863
  • 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
    Counter, differential cell - Product Code GKZ
  • Reason
    One lot of lot of bd trucount tubes may contain tubes from another lot. there is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.
  • Action
    BD Biosciences sent an Urgent Product Recall letter dated March 2016 to all affected customers on March 31, 2016 by Certified Mail, e-mail and direct delivery by Sales Associates. Letters instructed that any remaining inventory of the affected lot be discarded and that date files obtained using reagents from the affected lot be reviewed for the possibility of incorrect data. Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt3, 3) in the united State. For customers outside the US, customers should contact their local BD Biosciences representative or distributor. For questions regarding this recall call 408-954-6080.

Device

Device Recall BD Bioscience Trucount Absolute Counting Tubes
  • Model / Serial
    Model: 340334; Manufacaturing lot: 534964
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including MD, CA GA. WA. PA. CO. TN. FL. NC. DE. VA, CT, LA. NC, NY, OH, MN, NH and Internationally to China, Japan, and India.
  • Product Description
    BD Trucount Absolute Counting Tubes: || Model number: 340334 || IVD; || BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
  • Manufacturer
    Becton, Dickinson and Company, BD Biosciences

Manufacturer

Becton, Dickinson and Company, BD Biosciences
  • Manufacturer Address
    Becton, Dickinson and Company, BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1812
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA