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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Healthcare BR Assay for CA 27.29

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  Class 2 Device Recall Siemens Healthcare BR Assay for CA 27.29 see related information
Date Initiated by Firm November 14, 2012
Date Posting Updated December 11, 2012
Recall Status1 Terminated 3 on September 25, 2015
Recall Number Z-0507-2013
Recall Event ID 63682
510(K)Number K982680  
Product Classification System, test, immunological, antigen, tumor - Product Code MOI
Product Siemens Healthcare BR Assay for CA 27.29
250 Test Kits 03896216
50 Test Kit 02419937
Ref Kit (US only) 10340081

Intended Use 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.
Code Information All lot codes
Recalling Firm/
Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact
Manufacturer Reason
for Recall
Operating range of the ADVIA Centaur systems is 18¿C to 30¿C (64.4¿F to 86.0¿F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used.
FDA Determined
Cause 2
Device Design
Action Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers. These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature range to 20 -25 degrees C and for the DHEAS assay to reduce the instrument operating temperature range to 18 -26 degrees C when these assays are being used. These notices also direct customers to review the contents of the correction notice with their Laboratory Director or Medical Director. A confirmation fax-back form was included to ensure that all customers worldwide have been notified and have complied with the mandatory action. Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local technical support representative. For questions regarding this recall call 508-668-5000.
Quantity in Commerce 250 test =1678 and 50 test =2660 and Ref. 1196
Distribution Worldwide Distribution - USA (nationwide) and Internationally to the following countries: Argentina Australia Austria Azerbaijan Belgium Bosnia Herzeg. Brazil Canada Chile COLOMBIA Croatia Czech Republic Denmark Egypt Estonia Finland France Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Italy Japan Kazakhstan Latvia Lithuania Malaysia Mexico Netherlands New Caledonia Norway Oman P.R. China Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Reunion Romania Russian Fed. Saudi Arabia Serbia Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. United Kingdom Uruguay 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 = MOI and Original Applicant = CHIRON DIAGNOSTICS CORP.