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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur Progesterone Assay

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  Class 2 Device Recall ADVIA Centaur Progesterone Assay see related information
Date Initiated by Firm January 04, 2017
Create Date March 09, 2017
Recall Status1 Terminated 3 on July 18, 2019
Recall Number Z-1418-2017
Recall Event ID 76212
510(K)Number K932955  
Product Classification Radioimmunoassay, progesterone - Product Code JLS
Product ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111

Product Usage:
The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Code Information SMN: 10310305: 75422274 83380274 89389274 99473274 8713275 19796275 30565275 38674275 46515276 55704276 66971276 78934276 80930277;  SMN: 10315522: 74355274 80476274 87497274 20274 7772275 14822275 25943275 35303275 43229276 46525276 55505276 67430276 80448276 81415277;  SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276 
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		 DHEA-S causes falsely elevated progesterone results.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Siemens sent an Urgent Medical Device Correction (UMDC) letter dated January 4, 2017 to all affected Siemens Healthcare Diagnostics customers in the United States dated . An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on January 4, 2017. These letters identified the affected product problem and actions to be taken. For questions contact your local Siemens Customer Care Center or your local Siemens Technical support.
Quantity in Commerce 76,107
Distribution US Nationwide distribution including Puerto Rico
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 = JLS and Original Applicant = CIBA CORNING DIAGNOSTICS CORP.
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