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September 2021 : FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.
FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.
Affected Medical Device :
ADVIA®1800 Chemistry System
ADVIA®2400 Chemistry System
ADVIA®Chemistry XPT
MDA Reference Number : MDA/FCA/2021-P136
MDA Registration Number :
IVDB5744320-51063
IVDB5927720-49887
Decription : Siemens Healthcare Diagnostics Inc. has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results and potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_H) results.
Local Establishment Contact Detail :
Wilson Ng
Siemens Healthcare Sdn. Bhd.
Quality & Technology
HC APC ASN MAS QT
Level 16-1 & 16-2, CP Tower
No. 11, Jalan 16/11,Pusat Dagang Seksyen 16,46350 Petaling Jaya,Selangor Darul Ehsan, Malaysia
Tel: +60 3 79525555
Email : weil-shern.ng@siemens-healthineer
