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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Systems VitD Total 100 test, Ready Pack

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  Class 2 Device Recall ADVIA Centaur Systems VitD Total 100 test, Ready Pack see related information
Date Initiated by Firm April 10, 2014
Date Posted May 23, 2014
Recall Status1 Terminated 3 on May 27, 2016
Recall Number Z-1658-2014
Recall Event ID 67953
510(K)Number K110586  
Product Classification System, test, vitamin d - Product Code MRG
Product ADVIA Centaur Systems VitD Total 100 test, Ready Pack,
For OUS; SMN 10699201.

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: 050 08 August 2014 051 20 September 2014 052 11 December 2014 053 10 December 2014 054 07 March 2015 
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 2		 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 40,266 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 = MRG and Original Applicant = Siemens Healthcare Diagnostics Inc.
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