Siemens Dimension Assays (2016-03-22)

Starting date:

March 22, 2016

Posting date:

April 22, 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-58054

• Reason
• Affected products

Affected Products

A. DIMENSION VISTA SYSTEM - HIGH DENSITY LIPOPROTEIN CHOLESTEROL ASSAY
B. DIMENSION VISTA SYSTEM - URIC ACID ASSAY
C. DIMENSION VISTA SYSTEM - TRIGLYCERIDES ASSAY
D. DIMENSION CLINICAL CHEMISTRY SYS - ENZYMATIC CREATININE ECRE FLEX REAG CART
E. DIMENSION CLINICAL CHEMISTRY SYSTEM - TRIG/TRIGLYC
F. DIMENSION CLINICAL CHEMISTRY SYSTEM - URCA/URIC AC
G. DIMENSION VISTA SYSTEM - ENZYMATIC CREATININE ASSAY
H. DIMENSION EXL SYSTEM - ENZYMATIC CREATININE (EZCR) ASSAY
I. DIMENSION XPAND SYSTEM - ENZYMATIC CREATININE (EZCR) ASSAY
J. DIMENSION CLINICAL CHEMISTRY SYS. - AUTOMATED HDL
K. DIMENSION XPAND SYSTEM - AUTOMATED HDL CHOLESTEROL
L. DIMENSION EXL SYSTEM - AUTOMATED HDL CHOLESTEROL (AHDL) ASSAY
M. DIMENSION XPAND SYSTEM - TRIGLYCERIDES (TGL) ASSAY
N. DIMENSION XPAND SYSTEM - URIC ACID (URCA) ASSAY
O. DIMENSION EXL SYSTEM - TRIGLYCERIDES (TGL) ASSAY
P. DIMENSION EXL SYSTEM - URIC ACID (URCA) ASSAY

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-acetylcysteine (NAC) or metamizole administration due to the potential for falsely depressed results.

Affected products