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ADVIA Centaur
®
ADVIA Centaur
XP
System Misinterprets Wash 1 Fluid Signals
Our records indicate that you have received the ADVIA Centaur
(catalog number: 078-A001-xx ADVIA Centaur system, 078-A002R02 ADVIA Centaur
refurbished , 078-A011-03 ADVIA Centaur XP system, 078-A011R03 ADVIA Centaur XP
refurbished).
Reason for Voluntary Correction
Siemens Healthcare Diagnostics is conducting a voluntary field correction for the
ADVIA Centaur and ADVIA Centaur XP system.
Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed
occurrences of the system either:
•
Failing to detect that the Wash 1 bottle and reservoir is empty, or
•
Incorrectly indicating that the Wash 1 bottle and reservoir is empty when it is actually full.
If the system fails to detect an empty Wash 1 bottle and reservoir it can continue to process
samples and produce erroneous but believable results which are falsely high or low (depending
if the assay architecture is direct or indirect). This issue potentially affects only those assays that
use Wash 1 (Table 1).
Table 1.
Assays Potentially Affected
Assay Type
Auto-immune
Bone
Cardiovascular
Torch and Special ID
Reproductive Endocrinology
Infectious Disease
Immunosuppressant
Liver Fibrosis
Tumor Markers / Oncology
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics
GPF-003 -11 V1.0 Effective: September 21, 2012
Related Procedure: GP-003 DX- Field Correction Action
Assay
ANA
VitD
BNP, DDimer, TnIUltra
RUBG2, RubM, ToxG, ToxM
DHEAS, eE2, SHBG
aHAVM, aHAVT/HAVT, aHBcM, aHBcT/HBcT, aHBe, aHBs, aHBs, aHBs2,
aHCV, CHIV, CMVG, Conf, EHIV, HBeAg, HBs, HIV, PCT, SYPH
CsA
HA, PIINP, TIMP1
CA153, CA19-9, CA199A, FreePSA
511 Benedict Ave.
Tarrytown, NY 10591
All rights reserved.
Urgent Field Safety Notice
10813924, Rev. A
®
or ADVIA Centaur XP system
www.siemens.com/diagnostics
November 2012
Page 1 of 5
10813924, Rev. A
Related Manuals for Siemens ADVIA Centaur
Summary of Contents for Siemens ADVIA Centaur
- Page 1 Our records indicate that you have received the ADVIA Centaur or ADVIA Centaur XP system (catalog number: 078-A001-xx ADVIA Centaur system, 078-A002R02 ADVIA Centaur refurbished , 078-A011-03 ADVIA Centaur XP system, 078-A011R03 ADVIA Centaur XP refurbished). Reason for Voluntary Correction Siemens Healthcare Diagnostics is conducting a voluntary field correction for the ADVIA Centaur and ADVIA Centaur XP system.
- Page 2 If the system indicates that the Wash 1 bottle and reservoir is empty, the system will stop processing samples. Siemens does not recommend a review of past results because the issue can be detected by reviewing quality control (QC) results, and by visually checking the amount of fluid in the Wash 1 bottle.
- Page 3 Wash 1 in the bottle, then perform the following: Prime the Wash 1 fluid lines following instructions in the Operator’s Guide. Refer to the ADVIA Centaur XP Operator’s Guide or ADVIA Centaur Operator’s Guide for additional instructions. Call your local support representative and notify them that the red message displays when sufficient Wash 1 is present.
- Page 4 We apologize for the inconvenience this situation has caused. If you have any questions, please contact your Siemens Technical Solutions Center or your local Siemens technical support representative. ADVIA Centaur is a trademark of Siemens Healthcare Diagnostics.
- Page 5 Urgent Field Safety Notice dated November 2012 regarding System Misinterprets Wash 1 Fluid Signals 10813924. Please read each question and indicate the appropriate answer. Fax this completed form to Siemens Healthcare Diagnostics at the fax number indicated at the bottom of this page.