Events

Recall of Device Recall Active Renin IRMA 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
    63140
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2013
  • Event Initiated Date
    2012-01-20
  • Event Date Posted
    2012-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112672
  • 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, angiotensin i and renin - Product Code CIB
  • Reason
    The recall was initiated because beckman coulter has confirmed that the active renin irma test kit may exhibit a decrease in stability of the coated tubes. as a result, quality control and patient sample results may be falsely elevated by up to 72%.
  • Action
    Beckman Coulter sent an Urgent Production Correction letter dated January 10, 2012 to all their customers who purchased the Manual Immunoassay Active Renin IRMA Test Kit. The letter provides the customers with an explanation of the problem and actions to be taken. Customers were instructed to discontinue use and discard all remaining affected inventory. Customers were asked to complete and return the enclosed Response Form with in 10 days. Customers with questions contact Customer Service Support at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633.

Device

Device Recall Active Renin IRMA Kit
  • Model / Serial
    Lot # 110919D, 111017C, 111017D, 111114C, 111212C.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
  • Product Description
    Active Renin IRMA Kit, Part Number DSL25100 || Product Usage: || The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, MS/E1.NE.02, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA