Siemens Healthcare Diagnostics
Urgent Field Safety Notice
10813924, Rev. A
November 2012
ADVIA Centaur
®
ADVIA Centaur
®
XP
System Misinterprets Wash 1 Fluid Signals
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.
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
Assay
Auto-immune ANA
Bone VitD
Cardiovascular
BNP, DDimer, TnIUltra
Torch and Special ID
RUBG2, RubM, ToxG, ToxM
Reproductive Endocrinology
DHEAS, eE2, SHBG
Infectious Disease
aHAVM, aHAVT/HAVT, aHBcM, aHBcT/HBcT, aHBe, aHBs, aHBs, aHBs2,
aHCV, CHIV, CMVG, Conf, EHIV, HBeAg, HBs, HIV, PCT, SYPH
Immunosuppressant CsA
Liver Fibrosis
HA, PIINP, TIMP1
Tumor Markers / Oncology
CA153, CA19-9, CA199A, FreePSA
511 Benedict Ave.
Tarrytown, NY 10591 www.siemens.com/diagnostics
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10813924, Rev. A
GPF-003 -11 V1.0 Effective: September 21, 2012
Related Procedure: GP-003 DX- Field Correction Action
