Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantit…

Recall date

May 4, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2281-2020

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of North Carolina, California, Indiana, Florida, Ohio, Arizona, Massachusetts, New Jersey, New Hampshire, Illinois, Minnesota, Arkansas, New York, Delaware, Nevada, Kentucky, Washington DC, Montana, Missouri, Colorado, Mary…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.