Events

Recall of Device Recall IMMULITE 2000/2000 XPi Intact Parathyroid Hormone (IPTH)

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
    75837
  • Event Risk Class
    Class 2
  • Event Number
    Z-0979-2017
  • Event Initiated Date
    2016-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151436
  • 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
    Siemens is conducting this recall for the immulite¿ 2000/immulite¿ 2000 xpi intact pth (intact parathyroid hormone) (ipth) assay kit lot 320. siemens has confirmed that immulite¿ 2000/immulite¿ 2000 xpi intact pth kit lot 320 can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml with serum and edta patient samples vs. a reference kit lot.
  • Action
    The firm, Siemens, sent an "Urgent Medical Device Recall" letter IMC16-27.A.US (dated 11/22/2016) to its customers on 11/22/2016 via FedEx. Customers Outside the US were sent an "Urgent Field Safety Notice" dated 11/2016. The letter/notice describes the product, problem and actions to be taken. Customers were instructed to discontinue use of and discard the affected kit; review your inventory of these products to determine your laboratorys replacement needs; Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days by fax to the Customer Care Center at (312) 275-7795; and retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall IMMULITE 2000/2000 XPi Intact Parathyroid Hormone (IPTH)
  • Model / Serial
    Lot Number 320, exp. date 2016/11/30;  UDI #s: 0063041496191032020161130 and 0063041496192732020161130
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, China, Chile, Mexico, Australia, Austria, Bangladesh, Belgium, Bosnia Herzeg, Brazil, Bulgaria, Peru, Colombia, Ecuador, Bolivia, Costa Rica, Honduras, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Algeria, Greece, Guatemala, Hungary, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Netherlands, Norway, Pakistan, Panama, Paraguay, Poland, Portugal, Republic Korea, Romania, Russian Fed., Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Jordan, U.A.E., United Kingdom and Uruguay.
  • Product Description
    SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) || Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number (SMN) 10381441 and REF/Catalog Number L2KPP6, SMN 10381442; IVD --- Made in UK -- Siemens healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL UK || For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma and serum, as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA