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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Intact PTH (iPTH) Assay

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  Class 2 Device Recall ADVIA Centaur Intact PTH (iPTH) Assay see related information
Date Initiated by Firm October 03, 2008
Date Posted March 07, 2012
Recall Status1 Terminated 3 on March 08, 2012
Recall Number Z-1186-2012
Recall Event ID 60321
510(K)Number K020217  
Product Classification Radioimmunoassay, parathyroid hormone - Product Code CEW
Product ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138)
Cat. Nos.
100 Test kit 04385983 (129501)
500 Test kit 06587575 (129502).

For in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in EDTA plasma or serum using the ADVIA Centaur systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.
Code Information 500 Test Kits Kit Lot Number Expiry Date 17436138 15 January 2009 17601138 15 January 2009 19464138 15 January 2009 21240138 15 January 2009 23262138 15 January 2009 100 Test Kits Kit Lot Number Expiry Date 17435138 15 January 2009 18338138 15 January 2009 19929138 15 January 2009 20943138 15 January 2009 21835138 15 January 2009
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact SAME
508-359-3825
Manufacturer Reason
for Recall		 Poor sensitivity and imprecision on ADVIA Centaur¿ systems; Serum samples low bias; EDTA plasma samples low bias
FDA Determined
Cause 2		 Process control
Action Siemens sent an "URGENT FIELD SAFETY NOTICE" dated October 2008 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructed customer to immediately discontinue the use of ADVIA Centaur Intact PTH (iPTH) assay kits that contain intact PTH (iPTH) reagent lot 138. It also recommended that for serum samples analyzed on the ADVIA Centaur CP system, the content of the Urgent Field Safety Notice be discussed with their laboratory director to determine the need to review previous test results, conduct patient follow up, and repeat testing for iPTH results that were less than the upper limit of the reference range, and had a companion calcium result that was elevated or at the upper limit of normal. Additionally, a Completion Notification form was attached for customers to complete and return. Customers should contact their local technical support provider for questions regarding this recall.
Quantity in Commerce 100 Test =5768; 500 Test =1778
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Argentina, Chile, Columbia, Egypt, Finland, France, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, South Korea, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Uruguay, and Venezuela.
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 = CEW and Original Applicant = BAYER DIAGNOSTICS CORP.
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