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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Calibrator E

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  Class 2 Device Recall ADVIA Centaur Calibrator E see related information
Date Initiated by Firm February 04, 2016
Date Posted March 08, 2016
Recall Status1 Terminated 3 on August 01, 2017
Recall Number Z-1077-2016
Recall Event ID 73263
510(K)Number K932955  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack
Catalog Number: 04634452
SMN: 10309079
ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic use in the quantitative determination of total testosterone {bound and unbound) in serum using the ADVIA Centaur and ADVIA Centaur XP Systems
Code Information Lot codes/Exp Date: 87226A42 May 9, 2016; 55811 A42 May 9, 2016; 53650A42 May 9, 2016; 53624A42 May 9, 2016; 15612A43 November 27, 2016; 17909A43 November 27, 2016; 22868A43 November 27, 2016; 45084A43 November 27, 2016
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact SAME
508-668-5000
Manufacturer Reason
for Recall		 ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens Healthcare issued an Urgent Medical Device Correction (UMDC) to all affected Siemens Healthcare Diagnostics customers in the United States on February 4, 2016 to be delivered to customers on February 5, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to customers outside the United States on February 4, 2016. These notices inform the customers of the lot to lot bias of Calibrator E with the ADVIA Centaur Testosterone assay and advise customers to move to Calibrator E kit lots ending in 44. Fax-back forms will be used to confirm that the customers received the Urgent Medical Device Correction. Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative
Quantity in Commerce 15224 (2-pack)
Distribution Worldwide Distribution US (nationwide) and Internationally to: Canada AR AU BD BR CA CH CL CN CO DO EC GT HK ID IE IL IN JP KR LK MM MX MY NI NP NZ PE PH PY SA SG TH TW UY VN ZA
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 = JIX and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
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