Events

Recall of Device Recall BD CD8 (SK1) phycoerythrin (PE)

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

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
    70107
  • Event Risk Class
    Class 2
  • Event Number
    Z-1000-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132255
  • 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, cell, automated (particle counter) - Product Code GKL
  • Reason
    One lot of cd8 pe is contaminated with cd4 fitc and may cause an unexpected staining pattern and incorrect patient data.
  • Action
    Recall notification letters were sent to all consignees on December 19, 2014 by certified mail.

Device

Device Recall BD CD8 (SK1) phycoerythrin (PE)
  • Model / Serial
    Lot number 4220622, Expiry 2016-04-30.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
  • Product Description
    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. || Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
  • Manufacturer
    BD Biosciences, Systems & Reagents

Manufacturer

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