Siemens ADVIA Centaur Safety Notes

Siemens Healthcare DiagnosticsUrgent Field Safety Notice10813924, Rev. ANovember 2012ADVIA Centaur®ADVIA Centaur® XPSystem Misinterprets Wash 1 Fluid SignalsOur 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 Centaurrefurbished , 078-A011-03 ADVIA Centaur XP system, 078-A011R03 ADVIA Centaur XPrefurbished).Reason for Voluntary CorrectionSiemens Healthcare Diagnostics is conducting a voluntary field correction for theADVIA Centaur and ADVIA Centaur XP system.Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmedoccurrences 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 processsamples and produce erroneous but believable results which are falsely high or low (dependingif the assay architecture is direct or indirect). This issue potentially affects only those assays thatuse Wash 1 (Table 1).Table 1. Assays Potentially AffectedAssay Type AssayAuto-immune ANABone VitDCardiovascular BNP, DDimer, TnIUltraTorch and Special ID RUBG2, RubM, ToxG, ToxMReproductive Endocrinology DHEAS, eE2, SHBGInfectious Disease aHAVM, aHAVT/HAVT, aHBcM, aHBcT/HBcT, aHBe, aHBs, aHBs, aHBs2,aHCV, CHIV, CMVG, Conf, EHIV, HBeAg, HBs, HIV, PCT, SYPHImmunosuppressant CsALiver Fibrosis HA, PIINP, TIMP1Tumor Markers / Oncology CA153, CA19-9, CA199A, FreePSA511 Benedict Ave.Tarrytown, NY 10591 www.siemens.com/diagnostics Page 1 of 5Siemens Healthcare Diagnostics All rights reserved. 10813924, Rev. AGPF-003 -11 V1.0 Effective: September 21, 2012Related Procedure: GP-003 DX- Field Correction Action

/ 5

Related manuals for Siemens ADVIA Centaur