Class 2 Device Recall IMMULITE/IMMULITE 1000 Systems Androstenedione

• Date Initiated by Firm: December 20, 2013
• Date Posted: April 30, 2014
• Recall Status: Terminated on February 28, 2017
• Recall Number: Z-1531-2014
• Recall Event ID: 67211
• Product Classification: Radioimmunoassay, androstenedione - Product Code CIZ
• Product: IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL55 4EL, UK; ; For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 and 2000 Systems Analyzers for the quantitative measurement of 4-androstenedione in human serum.
• Code Information: Lot Numbers 409 and above
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics; 511 Benedict Ave; Tarrytown NY 10591-5005
• Manufacturer Reason for Recall: Siemens Healthcare Diagnostics confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). Siemens has determined that these lots are linear up to a concentration of 5.5 ng/mL, instead of 10 ng/mL as stated in the Instructions for Use (IFU). Quality Control materials at concentrations between 5.5 and 10 ng/mL will detect this issue.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated December 19, 2013, to its customers informing them that Siemens Healthcare Diagnostics has confirmed over-recovery of samples with concentrations greater than 5.5 ng/mL with the IMMULITE/IMMULITE 1000 and IMMULITE 2000/IMMULITE 2000 XPi Androstenedione assays (LKAO1, L2KAO2). The distribution of the customer communication began on 12/20/13 via FedEx (US). The letter described the product, problem and actions to be taken. Customers were instructed to take the following actions: - Please discuss this communication with your medical director. - Siemens recommends the use of Quality Control materials with at least two levels having concentrations less than 5.5 ng/mL. - Patient values of > 5.5 ng/mL should be verified using an alternate method. - and complete and return the Effectiveness Check questionnaire attached to the Urgent Field Safety Notice within 30 days and fax to: CUSTOMER CARE CENTER at 302-631-7597. Field service personnel were sent a Service Knowledge Base (SKB) describing the issue and instructing them how to deal with customer questions. If you have any questions, please call 1-914-524-3074 or contact your Siemens Customer Care Center or your local Siemens technical support representative.
• Quantity in Commerce: 892
• Distribution: Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Brazil, Canada, China (People's Republic of), Czech.Rebuplik, Denmark, Estonia, France, Germany, Great Britain, Italy, New Zealand, Portugal, Spain, Switzerland, Turkey and Vatican City.
• 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.