Events

Recall of PROCOUNT PROGENITOR CELL ENUMERATION KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECTON DICKINSON CANADA INC..

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
    20000
  • Event Risk Class
    III
  • Event Initiated Date
    2016-06-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Pouches contained in the kit lot 6083708 may not be sealed properly. the pouches contained in the kit can be identified with the lot no.16040 and are embossed with "17 02 16 t3" or "16 02 16 t3". improper storage of trucount tubes due to failed pouch closure can affect the performance of the counting beads leading to erroneous results in enumeration assays utilizing trucount. if the pouch seal is intact and the desiccant included in the pouch is blue the product may be used. if the pouch seal integrity is compromised and/or the desiccant has turned from blue to lavender discard the tubes because exposure to the ambient environment can rapidly degrade the performance of the product.

Device

PROCOUNT PROGENITOR CELL ENUMERATION KIT
  • Model / Serial
    Model Catalog: 340334 (Lot serial: 6083708)
  • Product Description
    BD Trucount tubes
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.