Events

Recall of Device Recall Siemens ADVIA Centaur iPTH ReadyPack 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
    65224
  • Event Risk Class
    Class 2
  • Event Number
    Z-1512-2013
  • Event Initiated Date
    2013-05-14
  • Event Date Posted
    2013-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118311
  • 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
    Ipth assay- reagent and calibrator lots may have demonstrated higher than anticipated variability.
  • Action
    Siemens sent an Urgent Medical Device Correction letter dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For questions, contact your Siemens Technical Solutions Center or your local Siemens technical support.

Device

Device Recall Siemens ADVIA Centaur iPTH ReadyPack Assay
  • Model / Serial
    Reagent Lot Number: 056301 and 56302 Kit Lot Number/Exp. Date: 61655301 09 Nov 2011 61950302 09 Nov 2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests; REF 10492368. || For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH).
  • 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