ADVIA Chemistry Systems (2016-03-22)

Starting date:

March 22, 2016

Posting date:

April 15, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-57946

• Reason
• Affected products

Affected Products

A. ADVIA CHEMISTRY SYSTEM - URIC ACID (UA) ASSAY
B. ADVIA CHEMISTRY SYSTEM - GLUCOSE OXIDASE (GLUO) ASSAY
C. ADVIA 1200 CHEMISTRY SYSTEM - DIRECT HDL CHOLESTEROL (D-HDL) ASSAY
D. ADVIA 1200 CHEMISTRY SYSTEM - URIC ACID (UA) ASSAY
E. ADVIA 1200 CHEMISTRY SYSTEM - DIRECT LDL CHOLESTEROL (DLDL) ASSAY
F. ADVIA 1200 CHEMISTRY SYSTEM - GLUCOSE OXIDASE (GLUO) ASSAY
G. ADVIA 1200 CHEMISTRY SYSTEM - LACTATE (LAC) ASSAY
H. ADVIA CHEMISTRY SYSTEM - ENZYMATIC CREATININE_2 (ECRE_2) ASSAY
I. ADVIA 1200 CHEMISTRY SYSTEM - ENZYMATIC CREATININE_2 ASSAY
J. ADVIA CHEMISTRY SYSTEM - DIRECT HDL CHOLESTEROL (D-HDL) ASSAY
K. ADVIA CHEMISTRY SYSTEM - DIRECT LDL CHOLESTEROL (DLDL) ASSAY
L. ADVIA CHEMISTRY SYSTEM - LACTATE (LAC) ASSAY
M. ADVIA 1200 CHEMISTRY SYSTEM - URIC ACID CONCENTRATED (UA_C) ASSAY
N. ADVIA CHEMISTRY SYSTEM - URIC ACID CONCENTRATED (UA_C) ASSAY
O. ADVIA 1200 CHEMISTRY SYSTEM - CHOLESTEROL CONCENTRATED (CHOL_C) ASSAY
P. ADVIA 1200 CHEMISTRY SYSTEM - CHOLESTEROL_2 (CHOL_2) ASSAY
Q. ADVIA CHEMISTRY SYSTEM - CHOLESTEROL CONCENTRATED (CHOL_C) ASSAY
R. ADVIA CHEMISTRY SYSTEM - CHOLESTEROL_2 (CHOL_2) ASSAY
S. ADVIA CHEMISTRY SYSTEM - GLUCOSE OXIDASE, CONCENTRATED REAGENTS (GLUO_C)
T. ADVIA 1200 CHEMISTRY SYSTEM - GLUCOSE OXIDASE, CONCENTRATED REAGENTS (GLUO_C)
U. ADVIA 1200 CHEMISTRY SYSTEM - FRUCTOSAMINE (FRUC) REAGENT
V. ADVIA CHEMISTRY SYSTEM - FRUCTOSAMINE (FRUC) REAGENT
W. ADVIA 1200 CHEMISTRY SYSTEM - TRIGLYCERIDES_2 REAGENT (TRIG_2)
X. ADVIA 1200 CHEMISTRY SYSTEM - TRIGLYCERIDES_2 CONCENTRATED REAGENTS (TRIG_C)
Y. ADVIA 1200 CHEMISTRY SYSTEM - TRIGLYCERIDES_2 REAGENT
Z. ADVIA CHEMISTRY SYSTEM - TRIGLYCERIDES_2 CONCENTRATED REAGENTS (TRIG_C)

Reason

Siemens Healthcare Diagnostics has become aware of N-acetylcysteine (NAC) and metamizole (dipyrone) interference with Trinder and Trinder-like reaction assays. The Trinder reaction is a reaction where hydrogen peroxide is formed and subsequently reacts with a phenol derivative and aminoantipyrine in the presence of peroxidase to form a coloured quinone product.
Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-acetylcysteine (NAC) or metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at significant risk for hepatotoxicity. Metamizole is an anti-inflammatory anti-pyretic drug banned in most countries because of the potential for nephrotoxicity.
The instructions for use (IFU) for the assays will be updated to indicate that: venipuncture should occur prior to n-acetyl cysteine (NAC) or metamizole administration due to the potential for falsely depressed results.

Affected products