Events

Recall of DHEA RIA 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
    57968
  • Event Risk Class
    Class 2
  • Event Number
    Z-2882-2011
  • Event Initiated Date
    2010-09-09
  • Event Date Posted
    2011-07-26
  • 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=97871
  • 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
    Radioimmunoassay, dehydroepiandrosterone (free and sulfate) - Product Code JKC
  • Reason
    The recall was initiated because beckman coulter has confirmed customer reports that dhea measurements using dhea ria (ref dsl-8900) kit lots identified may overstate actual dhea levels in patient samples.
  • Action
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTION ACTION" letter dated November 15, 2010 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected products and discard them according to local regulations. Customers were asked to review patient DHEA results ran on the affected lots and interpret them in light of additional tests (such as LH, FSH, testosterone, DHEA-S, cortisol, 17-hydroxyprogesterone, and estradiol) and the patient's clinical status. A response form was enclosed for customers to complete and return. Contact the Beckman Coulter Technical Support Center at 1-800-854-3633 in the United States, or their local Beckman Coulter Representative for questions regarding this notification.

Device

DHEA RIA Reagent
  • Model / Serial
    Lot numbers: 991112, 991346, 991584, 991857, 992115, 992359, 992458, 992854 were manufactured at: Beckman Coulter, Diagnostics Systems Laboratories, a Beckman Coulter Company, 445 West Medical Center Blvd, Webster, Texas 77598.  Lot numbers: 100115A, 100205A, 100205RA, 100226A, 100226RA, 100319A, 100319RA, 100409A, 100409RA, 100430A, 100430RA, 100521A, 100611A, 100611RA, 100702A, 100723A, 100723B, 100723RA, 100813A, 100813RB, 100813C were manufactured at: Immunotech, Prague, a Beckman Coulter Company, Radiova 1, Praha, 10227, Czech Republic.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Hungary, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Product Description
    DHEA RIA Reagent || The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is 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