Events

Recall of Device Recall IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions Diagnostics.

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
    49077
  • Event Risk Class
    Class 2
  • Event Number
    Z-0524-2009
  • Event Initiated Date
    2008-07-21
  • Event Date Posted
    2008-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72710
  • 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
    Progesterone Radioimmunoassay - Product Code JLS
  • Reason
    Siemens healthcare diagnostics has confirmed a long-standing high bias with lkpg 1, 5. (the bias is approximately 25% at 10 - 20 ng/ml as opposed to approximately 3% at 1-3 ng/ml - for more detail see the bias plot that is included with this notice.).
  • Action
    Siemens initiated the recall on 07/22/2008 by forwarding A Customer Bulletin by fax or mail to all affected Siemens Healthcare Diagnostic Branches for communication with the affected customers. The Customer Bulletin informed their customers that the firm is conducting a field correction and requested that they discontinue using any IMMULITE/IMMULITE 1000 kit lot prior to LKPG 1,5 330. They were also instructed to complete attached Completion Notification Form and return to their local Siemens Healthcare office or distributor as soon as possible. The were informed that replacement kits will be provided once the completed forms have been received. The Customer Bulletin recommend their customer discuss the content of the letter with their laboratory director regarding the need to review previous test results, conduct patient follow up, and/or repeat testing. The bias should not impact the in-vitro fertilization clinical application because the average change for samples within the range of 1-3 ng/mL is less than 5%. Although there is a greater degree of shift at higher concentrations, the clinical impact is considered to be relatively low when using the test for the diagnosis of ectopic pregnancy and luteal phase defects because in these situations, the progesterone result should always be considered in conjunction with other tests. PROGESTERONE DETERMINATIONS USED IN THE DIAGNOSIS OF PLACENTAL INSUFFICIENCIES OR FOR MONITORING PROGESTERONE THERAPY MAY HAVE BEEN AFFECTED BY THE HIGH BIAS. The letter also indicated SIEMENS IS INTRODUCING A RE-CALIBRATED IMMULITE PROGESTERONE KIT BEGINNING WITH KIT LOT LKPG1, 5 300, WHICH WILL BEGIN ROUTINELY SHIPPING AUGUST 15 TH. AT THAT TIME, KITS WITH THE PREVIOUS CALIBRATION WILL ONLY BE AVAILABLE UPON REQUEST AND AVAILABILITY OF INVENTORY FOR CUSTOMERS WHO STILL NEED TO PERFORM BASELINING STUDIES. An Important Notice, which is reproduced at the end of this notice below, will be included with the recalibrated kits

Device

Device Recall IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)
  • Model / Serial
    Lot Numbers: 318, 319, 320, 321, 322, 323, 324, 325, 326, and 327.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Argentina, Aruba, Australia, Austria, Bangladesh, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Nicaragua, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Republic of Panama, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Uruguay, and Venezuela.
  • Product Description
    IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) || For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of progesterone in serum, as an aid in the diagnosis and treatment of disorders of the ovaries or placenta.
  • Manufacturer
    Siemens Medical Solutions Diagnostics

Manufacturer

Siemens Medical Solutions Diagnostics
  • Manufacturer Address
    Siemens Medical Solutions Diagnostics, 1717 Deerfield Rd, Deerfield IL 60015-3900
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA