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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur XPT Immunoassay System

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 Class 2 Device Recall ADVIA Centaur XPT Immunoassay Systemsee related information
Date Initiated by FirmMay 26, 2016
Create DateJuly 21, 2016
Recall Status1 Terminated 3 on June 07, 2018
Recall NumberZ-2256-2016
Recall Event ID 74309
510(K)NumberK141999 
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
ProductADVIA Centaur XPT system 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) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Code Information none
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		Eight (8) issues were identified which may affect the results generated by the system software version.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn May 26, 2016, Siemens Healthcare Diagnostics Inc. distributed an Urgent Medical Device Correction notices to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers are advised to complete and return the Field Correction Effectiveness Check form within 30 days via fax to (312) 275-7795. For questions contact your local Siemens technical support representative.
Quantity in Commerce446 units Total (3 domestically & 443 internationally)
DistributionWorldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Republic Korea, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom & Vietnam.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JLW
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