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
|