|
Class 2 Device Recall ADVIA Centaur XPT System |
|
Date Initiated by Firm |
February 02, 2017 |
Date Posted |
February 23, 2017 |
Recall Status1 |
Terminated 3 on June 22, 2018 |
Recall Number |
Z-1537-2017 |
Recall Event ID |
76485 |
510(K)Number |
K141999
|
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
|
Product |
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels; Separates solid and liquid wastes; Measures photon emissions; Performs data reduction; Collects and maintains patient demographics and results. |
Code Information |
All Serial Numbers; Software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781, 11219656), V1.1 (Bundle 1.1.243 SMN 11221979, 11222064) and V1.2 (Bundle: 1.2.223.0 SMN: 11222258, 11223813). |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact |
Customer Care Center 312-275-7795
|
Manufacturer Reason for Recall |
Multiple software issues, which may affect the operation and workflow of the system. Potential for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may impact all analytes available on the ADVIA Centaur XPT System test menu.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens sent an Urgent Medical Device Correction letter ( UMDC) dated February 2, 2017. An Urgent Field Safety Notice letter ( UFSN) dated February 2017, was also sent to foreign customers.
Customers must follow instructions in the UMDC and UFSN letters. For questions, please contact your Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795. |
Quantity in Commerce |
US: 17 units; Foreign: 712 units |
Distribution |
Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and WA, and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Myanmar, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, and Vietnam. |
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 = JJE and Original Applicant = Siemens Healthcare Diagnostics Inc.
|
|
|
|