Events

Recall of Device Recall BD Biosciences Trucount(TM) 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
    74537
  • Event Risk Class
    Class 2
  • Event Number
    Z-2252-2016
  • Event Initiated Date
    2016-06-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147864
  • 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 bd trucount absolute counting tubes (ivd) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.
  • Action
    Urgent Product Correction notifications letters were sent on June 24, 2016 to all affected customers. Letters identify the issue and product and provide illustrations of the Kit Box and pouch labels. Correction letters identified the issue and the product involved with photos of product labels. BD letters states that they want to reinforce the need to visually inspect the desiccant contained in each pouch . If the desiccant has turned from blue to lavender, discard the remaining tubes. The acknowledgement form should be completed and returned regardless if any inventory remains. If you require further assistance, please contact BD Customer Support at 855.236.2772 (prompt 3) in the Unites States. For customers outside the US, contact your local BD Biosciences representative or distributor

Device

Device Recall BD Biosciences Trucount(TM) tubes
  • Model / Serial
    Catalog 340334, Lot ;6083708 (embossing ID of (160216T3)
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Distribution to the states of : NC, WA, WI, NJ, PR, MD, NY, MA, CA, NY , MD, KY, IN, VA, SD, PA, OH, AR, AZ and Foreign to : Canada, Belgium and Chile
  • Product Description
    BD Trucount Tubes: || Catalog number: 340334 || Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
  • 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