Events

Recall of Coulter Clone B6-FITC Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    26359
  • Event Risk Class
    Class 2
  • Event Number
    Z-1071-03
  • Event Initiated Date
    2003-04-28
  • Event Date Posted
    2003-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28579
  • 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
  • Reason
    Diminished expression on b-cell populations when drawn in edta tubes, which may lead to inaccurate interpretation of phenotype results. it was determined that choice of anticoagulant may have an effect on results for this reagent. the cd23 clone has shown a diminished expression on b-cell populations when drawn on edta tubes, which may lead to inaccurate interpretation of phenotype results.
  • Action
    Customer letters will be sent to all known purchasers on or about 4/28/2003, also existing inventory will be reworked to include a letter describing performance issues when collection occurs using EDTA.

Device

Coulter Clone B6-FITC Reagent
  • Model / Serial
    Lots 735512F, 735513F and 735514FR
  • Distribution
    Nationwide and to Canada
  • Product Description
    Coulter Clone B6-FITC Reagent
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 South Kraemer Blvd W 337, Brea CA 92822
  • Source
    USFDA