Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 ( ...



Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. [Note: the Atellica IM anti-CCP IgG (aCCP) assay was introduced for sale through the Replacement Reagent Policy.]
Components:
Recall Date:    Aug 14, 2019
Mfg:
Siemens Healthcare Diagnostics, Inc
Mfg Country:
United States
Recall ID:    83653
Product ID:    176028
Enforcement Date:    Oct 2, 2019
Last Published:    Sep 26, 2019

__________

Emert Number:    Z-2754-2019
Emert Status:    Announced