Events

Recall of Device Recall Access Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Systems

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
    76838
  • Event Risk Class
    Class 2
  • Event Number
    Z-1833-2017
  • Event Initiated Date
    2017-03-10
  • Event Date Posted
    2017-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154369
  • 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 (two-site solid phase), ferritin - Product Code JMG
  • Reason
    Beckman coulter is recalling the access ferritin calibrators kit because it contains a calibration card with an incorrect s5 calibrator concentration.
  • Action
    Beckman Coulter sent an Urgent Medical Device Recall letter dated March 10, 2017, to inform them that Beckman Coulter has determined through customer feedback that a portion of the Access Ferritin Calibrators kit lot listed above contains a calibration card with an incorrect S5 calibrator concentration. The S5 concentration value printed on the card and encoded in the barcode is 1.500 (ng/mL) rather than the correct concentration of 1500 (ng/mL). Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Technical Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 the US and Canada and customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

Device

Device Recall Access Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Sy...
  • Model / Serial
    Lot No. 671094
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.
  • Product Description
    Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
  • 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