Events

Recall of Device Recall Active Cortisol EIA

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
    55227
  • Event Risk Class
    Class 2
  • Event Number
    Z-2761-2011
  • Event Initiated Date
    2009-07-20
  • Event Date Posted
    2011-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90374
  • 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, cortisol - Product Code CGR
  • Reason
    The recall was initiated because beckman coulter has confirmed that the listed lot numbers of active control elisa reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. beckman coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica.
  • Action
    Beckman Coulter sent a Product Corrective Action (PCA) letter dated July 13, 2009. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use until further notice and discard remaining affected product. Customers were instructed to contact Beckman Coulter at 1-800-231-7970. Newer lots (lot number 991069 or higher) of the product have been recalibrated to restore the performance as described in the Instructions for Use (IFU). For method correlation information, please contact Technical Support at the phone number listed below. Consignees were asked to share this information with laboratory staff and retain the PCA letter for their Quality System documentation, and complete and return the enclosed Response Form within 10 days so that the firm can be assured that they received the notification. Questions regarding this notification were directed to the DSL Technical Support Center at 1-800-231-7970 in the United State and Canada, or their local Beckman Coulter Representative.

Device

Device Recall Active Cortisol EIA
  • Model / Serial
    Lot Numbers Epiration Dates 04195 8/15/2006 04195A 10/18/2006 04195B 1/26/2006 04195D 8/15/2006 04195E 10/18/2006 04195F 10/18/2006 09266A 01/31/2006 09266 10/17/2007 04126A 10/11/2007 04126 7/28/2007 03066A 09/05/2007 03066 09/05/2007 01036 07/02/2007 716217 06/06/2008 716218 07/29/2008 800408 05/07/2009 800409 05/07/2009 800410 05/07/2009 890829 09/03/2009 990168 09/03/2009
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    Active Cortisol EIA, 96 Wells, DSL-10-2000 || The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. 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