Events

Recall of Device Recall Access Immunoassay Systems Unconjugated Estriol

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
    59235
  • Event Risk Class
    Class 2
  • Event Number
    Z-3023-2011
  • Event Initiated Date
    2009-12-08
  • Event Date Posted
    2011-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101912
  • 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
    Radioimmunoassay, estriol - Product Code CGI
  • Reason
    The recall was initiated because beckman coulter has confirmed customer reports that a single lot of access unconjugated estriol reagent (pin 33570) may produce suppressed patient results and an increased incidence of ind (indeterminate) flags. these issues have been associated with reagent lot 913348. this reagent met all testing specifications prior to release.
  • Action
    Beckman Coulter sent a PRODUCT CORRECTIVE ACTION (PCA) letter dated December 8, 2009, to all affected customers. The letter was sent via US Postal Service for all US customers with attached PCA response form. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of Access Unconjugated Estriol reagent lot number 913348. " No further orders of Access Unconjugated Estriol reagent lot number 913348 will be shipped. " Abnormally low Access Unconjugated Estriol results from samples tested previously with the affected lot should be reviewed in the context of other diagnostic tests. " Access Unconjugated Estriol results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. Rerun any tests that produce a questionable result. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at (800) 854-3633 in the US and Canada. Outside of Canada and the US, customers were instructed to contact their local Beckman Coulter Representative.

Device

Device Recall Access Immunoassay Systems Unconjugated Estriol
  • Model / Serial
    Lot # 913348
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.
  • Product Description
    Access¿ Immunoassay Systems || UNCONJUGATED ESTRIOL || Part # 33570 || The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
  • 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