||December 11, 2012
|Recall Event ID
Enzyme Immunoassay, Digitoxin - Product Code LFM
||Siemens Healthcare ADVIA Centaur Digitoxin (DGTN)
250 Test 09046419
50 Test 08861968
Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
||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
||50 test=792 and 250 test=525
||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 = LFM and Original Applicant = CHIRON DIAGNOSTICS CORP.