Siemens Medical Solutions Diagnostics: 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.

Recall number

Z-0524-2009

Recalling firm

Siemens Medical Solutions Diagnostics

Product

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.

Status

Terminated

Initiated

2008-07-21

Posted

2008-12-23

Terminated

2012-07-25

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.).

Root cause

Other

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

Quantity

12,908

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.

Lot, serial or model codes

Lot Numbers: 318, 319, 320, 321, 322, 323, 324, 325, 326, and 327.

510(k) numbers

["K944211"]

PMA numbers

not on file

Product code

JLS

Firm FEI

3005250747

Firm city

Deerfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy