Events

Recall of Estrone Radioimmunoassay (RIA) Kit

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
    56399
  • Event Risk Class
    Class 2
  • Event Number
    Z-1685-2011
  • Event Initiated Date
    2010-04-22
  • Event Date Posted
    2011-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93491
  • 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 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 data.
  • Extra notes in the data
    Estrone Radioimmunoassay - Product Code CGF
  • Reason
    Beckman coulter has confirmed that eight estrone ria kit (ref dsl 8700) lots are inaccurately calibrated to the firm's internal reference calibrator. lots 992637, 100115a, 100205a, 100205ra, and 100226a have now expired and should not be in active use any more.
  • Action
    Beckman Coulter released an Urgent: Product Corrective Action letter dated July 9, 2010 identifying the affected product and informing consignees of the reason for recall, asking them to take the following actions: *For lots 992637, 100115A, 100205A, 100205RA, and 100226A, review historical external quality control results relevant to the patients' results obtained with these lots to ensure the assay performance was within laboratory specifications. *For lots 100319A, 100409A, 100409RA, review patents' results obtained with the results of external quality control and interpret them in the light of additional applicable tests, patient's clinical status and clinical history of patient. Beckman Coulter has finalized the process of re-adjusting Estrone calibrators' values assignment to the new internal reference calibrator starting with lot 100403A. If consignees need products for additional tests they were told to follow replacement instructions below: *In the United States, please contact Customer Service at 1-800-526-3821 *Outside the United States, contact your local Beckman Coulter Representative. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. They were to also complete and return the enclosed response form within 10 days so the firm can be assured that consignees received the notification. Consignees were instructed to forward any other questions regarding the notification to the DSL Technical Support Center at 1-800-231-7970 in the United States, or contact their local Beckman Coulter Representative.

Device

Estrone Radioimmunoassay (RIA) Kit
  • Model / Serial
    Lot numbers: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada.
  • Product Description
    Estrone Radioimmunoassay (RIA) Kit, DSL-8700. || Intended for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA