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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens ADVIA Centaur BR Assay

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  Class 2 Device Recall Siemens ADVIA Centaur BR Assay see related information
Date Initiated by Firm September 11, 2012
Date Posted October 28, 2012
Recall Status1 Open3, Classified
Recall Number Z-0162-2013
Recall Event ID 63167
510(K)Number K982680  
Product Classification System, test, immunological, antigen, tumor - Product Code MOI
Product Siemens ADVIA Centaur BR Assay: Catalog Number:
US: REF 02419937 (10214722) (50 Tests);
REF 03896216(10334837)(250 Tests) Not
CE Marked; OUS:
REF03204829(10310271)(50 Tests); REF
01157807(1 0314722) (250 Tests) CE
Marked; REF 09010686 (10340081)(250 Tests).

The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.
Code Information BR Assay for CA 27.29 BR Assay Kit Lots, ReadyPack¿ Lot Number Ending in 198:. 89291198,86469198,85752198,88939198,, 87757198, 85459198, 88319198, 86295198,, 85194198 , ReadyPack¿ Lot Number Ending in 202: , 93573202, 91045202, 93664202, 90880202,, 93157202,91126202,90494202.

BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199:, 87425199,85862199,86949199,85945199
Recalling Firm/
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
Manufacturer Reason
for Recall
BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges.
FDA Determined
Cause 2
Under Investigation by firm
Action Siemens sent two "URGENT FIELD SAFETY NOTICE" letters dated August and September 2012 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. A Field Correction Effectiveness Check Form was included for customers to complete and return.
Quantity in Commerce 15,455 kits
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Columbia, Japan, Korea, Mexico, New Zealand, Peru, Saudi Arabia, and Spain.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MOI and Original Applicant = CHIRON DIAGNOSTICS CORP.