Events

Recall of Anti EpCam PE Analyte Specific Reagent Catalog

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
    67948
  • Event Risk Class
    Class 2
  • Event Number
    Z-1536-2014
  • Event Initiated Date
    2014-04-04
  • Event Date Posted
    2014-05-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126643
  • 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
    Reagents,specific,analyte - Product Code MVU
  • Reason
    Two lots of anti epcam pe-analyte specific reagent are mislabeled - the actual antibody present in the vial is cd9 pe.
  • Action
    Customer product recall notification letters were sent to all consignees on April 4, 2014 by certified mail.

Device

Anti EpCam PE Analyte Specific Reagent Catalog
  • Model / Serial
    Catalog number 347211; Lot number 3295974 - expiry date 2015-09-30; Lot number 3259822 - expiry date 2015-09-30.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of CA, TX, FL, MO, NY, MI, MO, and AZ and Seoul, Korea.
  • Product Description
    Anti EpCam PE - Analyte Specific Reagent. || Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
  • 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