Class 2 Device Recall IMMULITE 2000 Systems T3F (Free T3)

• Date Initiated by Firm: August 27, 2013
• Date Posted: January 30, 2014
• Recall Status: Terminated on February 28, 2017
• Recall Number: Z-0868-2014
• Recall Event ID: 66055
• 510(K)Number: K974634
• Product Classification: Radioimmunoassay, total triiodothyronine - Product Code CDP
• Product: T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL UK.; ; For the quantitative measurement of Free T3 in serum, as an aid in the clinical assessment of thyroid status.
• Code Information: Lot Numbers 737, 738, 739, 740, 741, 742, 743
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics; 511 Benedict Ave; Tarrytown NY 10591-5005
• For Additional Information Contact: Siemens Customer Care Center; 877-229-3711
• Manufacturer Reason for Recall: Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the Instructions For Use for the IMMULITE/IMMULITE 1000 and/or IMMULITE 2000/IMMULITE 2000 XPi for several lots of Free T3 kits. A positive bias in quality control results was also observed, but the values may remain within the established ranges.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Urgent Medical Device Recall Letters (dated 8/27/13) and Field Recall Effectiveness Check Forms were sent to the affected customers (starting on 8/27/13) informing them to discontinue use of and discard the IMMULITE Free T3 reagent kit lots. Customers were instructed to contact their local Siemens representative for assistance. Customers are requested to complete and return the Effectiveness Check Form included with the recall letter within thirty (30) days.
• Quantity in Commerce: 4695 kits in total
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Bosnia-Herzegovina, Brazil, Belarus, Canary Islands, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Great Britain, Greece, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Ireland, Israel, Iran, Italy, Jordan, Republic of South Korea, Kuwait, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Mexico, Malaysia, Malta, Nepal, Netherlands, Norway, Panama, Peru, Philippines, Pakistan, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sri Lanka, South Africa, Switzerland, Turkey, Thailand, Taiwan, Uruguay, Usbekistan, Venezuela, Vietnam, and United Arab Emirates.
• 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 = CDP and Original Applicant = DIAGNOSTIC PRODUCTS CORP.