Events

Recall of Device Recall Access Immunoassay Systems Total T4 Calibrators

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
    59239
  • Event Risk Class
    Class 2
  • Event Number
    Z-3027-2011
  • Event Initiated Date
    2010-08-26
  • Event Date Posted
    2011-08-16
  • 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=101937
  • 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
    Enzyme immunoassay, non-radiolabeled, total thyroxine - Product Code KLI
  • Reason
    The recall was initiated because beckman coulter has confirmed that the stability claims for the access total t4 calibrators may not be met. this issue is associated with calibrator lots 917074 and 008534.
  • Action
    Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.

Device

Device Recall Access Immunoassay Systems Total T4 Calibrators
  • Model / Serial
    Lot Number: 917074, 008534  Expiration Date: 917074 (12/31/10), 008534 (2/28/11)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    Access¿ Immunoassay Systems Total T4 Calibrators, || Part Number: 33805, || Subsequent Product Code: JIS || The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma 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