Health product recall

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

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

A. Dimension Vista System Enzymatic Creatinine Assay (ECREA)

Lot or serial number

19035AA

19101AA

19175AA

19189AA

19192AB

19218AB

19273AA

19336AA

20027AC

20083AA

Model or catalog number

K1270A

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES


B. Dimension EXL System  Enzymatic Creatinine (EZCR) Assay

Lot or serial number

BB0262

BC9345

ED0086

FB0122

FC0324

FC9310

GC0024

GC0184

GD0218

GD9262

Model or catalog number

10471520

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES