Class 2 Device Recall ADVIA Centaur Systems TSH3 Ultra Ready Pack

• Date Initiated by Firm: April 10, 2014
• Date Posted: May 23, 2014
• Recall Status: Terminated on May 27, 2016
• Recall Number: Z-1653-2014
• Recall Event ID: 67953
• 510(K)Number: K083844
• Product Classification: Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
• Product: ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
• Code Information: Kit lots ending in/Exp Date: 266 17 April 2014 267 17 June 2014 269 01 August 2014 270 30 September 2014 271 18 November 2014 272 21 January 2015 273 18 November 2014
• 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: Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D and the ADVIA Centaur BRAHMS Procalcitonin assays.
• FDA Determined Cause: Device Design
• Action: Siemens Healthcare Urgent Medical Device Correction (UMDC) was mailed to all affected Siemens Healthcare Diagnostics customers in the United States on April 11, 2014 for customer receipt on April 14, 2014. This notice informed the customers of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra and Vitamin D Total assays. This notice instructs customers that the TSH3-Ultra and Vitamin D assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facility's laboratory or medical director. B. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on April 10, 2014. This notice informed the customer of fluorescein interference with the ADVIA Centaur Systems TSH3-Ultra , Vitamin D Total and ADVIA Centaur BRAHMS Procalcitonin assays. This notice instructs customers that the TSH3-Ultra, Vitamin D and Procalcitonin assays can continue to be used for testing any sample that does not contain fluorescein. However, testing blood drawn from a patient, without allowing clearance of fluorescein is not recommended. This notice should be reviewed with the facilitys laboratory or medical director. (Note: The ADVIA Centaur BRAHMS Procalcitonin assay is not sold in the US.)
• Quantity in Commerce: 22,770 kits
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Afghanistan Algeria Armenia Austria Bahrain Belgium Bulgaria Burkina Faso Canary Islands Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Great Britain Greece Hungary Iceland Iran Iraq Ireland Israel Italy Jordan Kazakhstan Latvia Lebanon Lithuania Luxembourg Macedonia Malta Netherlands Norway Oman Pakistan Poland Portugal Qatar Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir. Vatican Yemen.
• 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 = JLW