Events

Recall of BD CD3 (SK7) FITC

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
    72321
  • Event Risk Class
    Class 3
  • Event Number
    Z-0171-2016
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140615
  • 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
    Assay, t lymphocyte surface marker - Product Code LIZ
  • Reason
    Two lots of cd3 (sk7) fitc label contains an error in the spanish small text.
  • Action
    BD sent an "URGENT PRODUCT RECALL" letter dated September 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer Actions: 1. Discard all remaining stock of CD3 (SK7) FITC, catalog number 349201, lot number 5148598, and/or catalog number 340542, lot number 5113983, and request replacement product. BD will replace product at no cost. 2.As a requirement of our Regulatory Tracking Process, we request that you complete the enclosed Tracking Verification form, even if you no longer have the affected reagents listed in your inventory. Please return the Tracking Verification form to BD Biosciences, per the instructions (mail, fax, or email). We apologize for any inconvenience that this may have caused and are working toward a long-term solution to this issue. If you require further assistance, please contact BD Customer Support at 877.232.8995 (prompt 3, 3) in the United States. For customers outside the US, contact your local BD Biosciences representative or distributor.

Device

BD CD3 (SK7) FITC
  • Model / Serial
    Catalog Number: 349201; Lot Number 5148598 (expires 10-31-2016) Catalog Number: 340542; Lot Number 5113983 (expires 02-28-2017)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) Distribution to the states of : TX, GA, IN, TN, CA, KY, WA, IL, MO, NY, CT, MN, NV, KS, WI, NH, FL, PA, OH, OR, SC. OK, NC and LA., and Internationally to Mexico.
  • Product Description
    BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 || Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
  • 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