medical Class II Updated 2020-06-17

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Fructosamine Reagent (FRUC), Siemens Material Nu

Recalled Product

Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding two-three weeks.


Hazard / Issue

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 291011 ***Added 9/9/20*** 201115
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →