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