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U.S. Department of Health and Human Services

Class 2 Device Recall radioimmunoassay, total triiodothyronine

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  Class 2 Device Recall radioimmunoassay, total triiodothyronine see related information
Date Initiated by Firm July 28, 2017
Create Date February 26, 2018
Recall Status1 Terminated 3 on April 03, 2019
Recall Number Z-0720-2018
Recall Event ID 79170
510(K)Number K041133  
Product Classification Radioimmunoassay, total triiodothyronine - Product Code CDP
Product ADVIA Centaur¿ T3

ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and treatment of thyroid disease.
Code Information x
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		 Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens sent an Urgent Medical Device Correction letter dated July 28, 2017, that was distributed to all customers in the United States and an Urgent Field Safety Notice was distributed to all customers outside the United States. On August 15, 2017 Follow-up communication was sent to all customers. For further questions, please call (508) 668-5000.
Quantity in Commerce 33,298
Distribution Worldwide Distribution - US Distribution.
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 = CDP and Original Applicant = BAYER HEALTHCARE, LLC
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