Class 2 Device Recall ADVIA Centaur Cortisol Assay

• Date Initiated by Firm: March 06, 2012
• Date Posted: April 09, 2012
• Recall Status: Terminated on June 26, 2015
• Recall Number: Z-1390-2012
• Recall Event ID: 61393
• 510(K)Number: K962559
• Product Classification: Fluorometric, cortisol - Product Code JFT
• Product: Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF Test kit ADVIA Centaur Systems Cortisol: For in vitro diagnostic use in the quantitative determination of cortisol in serum or urine using the ADVIA Centaur and ADVIA Centaur XP systems.
• Code Information: AD VIA Centaur¿ Cortisol reagent kit lots from the reagent lots ending with the following three digits: 254, 255, 256, 257. Kit Lot# 50 Test 70078254 70860254 72058254 73346254 74543254 75397254 76332255 77366255 78595255 79146255 80596255 81274255 82938256 83522256 84771256 86150257 250 Test 69991254 70470254 73049254 74027254 76202255 78071255 80179255 81497255 82689256 83316256 86138257 250 Test 73880254 77890255 80812255 83456256 86151257 Not Applicable . Expiry Date 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 15 Feb 2013 09 May 2013 23 May 2012 23 May 2012 23 May 2012 23 May 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 15 Feb 2013 09 May 2013 05 May 2012 07 Oct 2012 07 Oct 2012 15 Feb 2013 09 May
• Recalling Firm/ Manufacturer: Siemens Healthcare Diagnostics, Inc; 333 Coney St; East Walpole MA 02032-1516
• For Additional Information Contact: 508-668-5000
• Manufacturer Reason for Recall: Cortisol Assay reagent kit lots do not meet onboard stability and calibration interval claims
• FDA Determined Cause: Component design/selection
• Action: The firm, Siemens Healthcare, sent an "Urgent Field Safety Notice" via e-mail to all affected customers on March 6, 2012 in the United States and International. The Urgent Field Safety Notice describe the product, problem, and actions to be taken. The notice instructed the customers to perform daily calibration on all Cortisol reagent kits to maintain consistently accurate quality control and patient values; to complete and return the confirmation fax-back form 'Field Correction Effectiveness Check' via fax to the Technical Solutions Center at (302) 631-7597 and forward this notification to whomever they many have distributed this product. If you have any questions, contact Quality Engineer 5- Quality Systems and Compliance at 508-660-8540 or www.siemens.com/diagnostics.
• Quantity in Commerce: Total: 40023. 50 Test Kits = 21734;250 Test Kits= 15879;250 REF Test Kits= 2410
• Distribution: Worldwide distributed: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRALIA, BANGLADESH, BD, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, EGYPT, GERMANY, HONG KONG, INDIA, INDONESIA, IRELAND, ISRAEL, JAPAN, KOREA, MALAYSIA, MEXICO, NEW ZEALAND, PAKISTAN, PHILIPPINES, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, TAIWAN, THAILAND, URUGUAY, VENEZUELA, and VIETNAM.
• 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 = JFT