Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall ADVIA Centaur CP

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall ADVIA Centaur CP see related information
Date Initiated by Firm March 30, 2016
Date Posted May 06, 2016
Recall Status1 Terminated 3 on March 29, 2017
Recall Number Z-1615-2016
Recall Event ID 73801
510(K)Number K041133  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers.

This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ranjan Sadarangani
914-524-2868
Manufacturer Reason
for Recall		 The firm identified an issue in sample processing when using EZee-Nest Insert Cups due to two inaccuracies that exist in the ADVIA Centaur CP Operators Guide.
FDA Determined
Cause 2		 Use error
Action Siemens sent an Urgent Medical Device Correction letter dated March 2016, to all affected customers. The letter was sent to the US customers via Fed Ex beginning on March 30, 2016., and were e-mailed dated March 20, 2016, to regional countries for implementation outside the US. Field service personnel were sent a support bulletin describing the issue and instructing them how to manage customer questions. " Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days. " Please review this letter with your Medical Director. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions, please call (914) 524-2868.
Quantity in Commerce US: 442 units; Foreign: 3237 units
Distribution Worldwide Distribution - USA (nationwide) and to the countries of : Afghanistan, Albania, Algeria, Angola, Argentina, Australia, Austria, Bangladesh, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Caledonia, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uganda, United Kingdom, Uruguay, Vietnam, Yemen.
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 = BAYER HEALTHCARE, LLC
-
-