Events

Recall of ADVIA Centaur Intact PTH (iPTH) Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Healthcare Diagnostics, 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
    60321
  • Event Risk Class
    Class 2
  • Event Number
    Z-1186-2012
  • Event Initiated Date
    2008-10-03
  • Event Date Posted
    2012-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105030
  • 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, parathyroid hormone - Product Code CEW
  • Reason
    Poor sensitivity and imprecision on advia centaur¿ systems; serum samples low bias; edta plasma samples low bias.
  • Action
    Siemens sent an "URGENT FIELD SAFETY NOTICE" dated October 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructed customer to immediately discontinue the use of ADVIA Centaur Intact PTH (iPTH) assay kits that contain intact PTH (iPTH) reagent lot 138. It also recommended that for serum samples analyzed on the ADVIA Centaur CP system, the content of the Urgent Field Safety Notice be discussed with their laboratory director to determine the need to review previous test results, conduct patient follow up, and repeat testing for iPTH results that were less than the upper limit of the reference range, and had a companion calcium result that was elevated or at the upper limit of normal. Additionally, a Completion Notification form was attached for customers to complete and return. Customers should contact their local technical support provider for questions regarding this recall.

Device

ADVIA Centaur Intact PTH (iPTH) Assay
  • Model / Serial
    500 Test Kits Kit Lot Number Expiry Date 17436138 15 January 2009 17601138 15 January 2009 19464138 15 January 2009 21240138 15 January 2009 23262138 15 January 2009 100 Test Kits Kit Lot Number Expiry Date 17435138 15 January 2009 18338138 15 January 2009 19929138 15 January 2009 20943138 15 January 2009 21835138 15 January 2009
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Chile, Columbia, Egypt, Finland, France, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, South Korea, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uruguay, and Venezuela.
  • Product Description
    ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) || Cat. Nos. || 100 Test kit 04385983 (129501) || 500 Test kit 06587575 (129502). || For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA