||December 11, 2012
|Recall Event ID
System, Test, Immunological, Antigen, Tumor - Product Code MOI
||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.
||All lot codes
|Siemens Healthcare Diagnostics, Inc
333 Coney St
East Walpole, Massachusetts 02032-1516
|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.
|DESIGN: Device Design
||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
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
||Worldwide Distribution - USA (nationwide) and Internationally to the following countries:
Rep. of Yemen
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = MOI and Original Applicant = CHIRON DIAGNOSTICS CORP.