| Class 2 Device Recall Siemens ADVIA Centaur CA 199 Assay (50 test kit) | |
Date Initiated by Firm | October 19, 2016 |
Create Date | November 17, 2016 |
Recall Status1 |
Terminated 3 on March 02, 2023 |
Recall Number | Z-0612-2017 |
Recall Event ID |
75523 |
510(K)Number | K031393 |
Product Classification |
System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
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Product | ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems.
Siemens Material Number(SMN): 10491379
In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT instrument. Siemens stated that the assay is being marketed on the XPT following FDAs Reagent Replacement Policy. Siemens plans to request CLIA Categorization for the CA19-9 assay on XPT the week of 11/21/2016. |
Code Information |
Kit lots ending in: 380 Exp Date 2016-10-21; 382/ 2017-01-09; 384 2017-02-06; 386 2017-03-24 ; 388 2017-05-14 ; 390 2017-06-12 . And all future lots until the issue is resolved. Siemens will also include a notecard in future lots of reagents referring customers to the communications . |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
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For Additional Information Contact | 508-668-5000 |
Manufacturer Reason for Recall | CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT
systems as stated in the Instructions for Use. |
FDA Determined Cause 2 | Process design |
Action | Siemens Healthcare issued Urgent Medical Device Correction (UMDC) to Siemens Healthcare Diagnostics customers in the United States on October 19, 2016 to be delivered to customers on October 20, 2016. An Urgent Field Safety Notice (UFSN) was sent out for distribution to all customers outside the United States on October 18, 2016. The notice informs the customer of the potential to observe a bias between CA 19-9 results generated on the ADVIA Centaur CP and the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Customers may continue
to use the ADVIA Centaur CA 19-9 assay to report patient results on the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT and ADVIA Centaur CP systems. Customers should not use the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems interchangeably with the ADVIA Centaur CP when generating CA 19-9 results.
For customers using the ADVIA Centaur CP and ADVIA Centaur/XP/XPT for CA 19-9 interchangeably, a look back of patient results over the previous three months is recommended.
A Field Correction Effectiveness Check is to be completed, signed and returned Siemens.
Questions, contact your Siemens Customer Care Center or your local Siemens technical support representative. |
Quantity in Commerce | 18,733 kits |
Distribution | Nationwide
Foreign:
Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Great Britain, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy,
Japan, Jordan, Kazakhstan, Latvia, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, Vatican City, Vietnam |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NIG
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