Events

Recall of Device Recall Manual Inhibin A ELISA Reagent Kit; Part Number DSL10281001

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
    58720
  • Event Risk Class
    Class 2
  • Event Number
    Z-2775-2011
  • Event Initiated Date
    2011-03-31
  • Event Date Posted
    2011-07-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100185
  • 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
    Inhibin-A Immunoassay - Product Code ndr
  • Reason
    The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the manual inhibin a elisa assay has shifted from the assays original calibration. erroneously elevated results may lead to unnecessary ultrasound testing to confirm gestational age, patient psychological stress until diagnostic testing is completed, and/or medical decis.
  • Action
    Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers. The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return. For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter representative.

Device

Device Recall Manual Inhibin A ELISA Reagent Kit; Part Number DSL10281001
  • Model / Serial
    Lot Number: 992363, 992739, 090499, 090498, 091055, 090798
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: (USA) Nationwide and the countries of Armenia, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Peru, Portugal, Romania, Russian Federation, Serbia, Slovenia, Spain, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-4 || The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA