Health product recall

ADVIA Chemistry System Enzymatic Creatinine_2 (ECRE_2) Assay & Fructosamine (FRUC) Reagent (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-73155

Last updated: 2020-05-22

Affected Products

A. ADVIA Chemistry System Enzymatic Creatinine_2 (ECRE_2) Assay
B. ADVIA Chemistry System  Fructosamine (FRUC) Reagent

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

A. ADVIA Chemistry System Enzymatic Creatinine_2 (ECRE_2) Assay

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

4992596

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

B. ADVIA Chemistry System  Fructosamine (FRUC) Reagent

Lot or serial number

477674
501874

Model or catalog number

10361941

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES