Class 2 Device Recall IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5)

• Date Initiated by Firm: July 21, 2008
• Date Posted: December 23, 2008
• Recall Status: Terminated on July 25, 2012
• Recall Number: Z-0524-2009
• Recall Event ID: 49077
• 510(K)Number: K944211
• Product Classification: Progesterone Radioimmunoassay - Product Code JLS
• 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.
• Code Information: Lot Numbers: 318, 319, 320, 321, 322, 323, 324, 325, 326, and 327.
• Recalling Firm/ Manufacturer: Siemens Medical Solutions Diagnostics; 1717 Deerfield Rd; Deerfield IL 60015-3900
• For Additional Information Contact: 310-645-8200
• Manufacturer Reason for Recall: 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.).
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JLS and Original Applicant = DIAGNOSTIC PRODUCTS CORP.