Dimension Vista System Enzymatic Creatinine Assay (ECREA) & EXL System Enzymatic Creatinine (EZCR) Assay (2020-05-08)

Starting date:

May 8, 2020

Posting date:

May 22, 2020

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-73157

Last updated: 2020-05-22

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  Reason
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  Affected products

Affected Products

A. Dimension Vista System Enzymatic Creatinine Assay (ECREA)

B. Dimension EXL System  Enzymatic Creatinine (EZCR) Assay

Reason

Siemens healthcare diagnostics has become aware that the presence of n-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. This interference may cause falsely depressed fructosamine and creatinine results in patient samples.

Currently, the "limitations of the procedure" sections in the affected assay instructions for use (IFU) do not indicated that NAPQI is a metabolite of acetaminophen and that certain concentrations of NAPQI (NAPQI concentrations specific to each affected assay) may lead to falsely depressed results for patient samples. The "limitations of the procedure" sections also do not state that the use of the assay is not recommended for patients being treated for an overdose of acetaminophen.

Affected products