FDAFDA · Food and drugs·Recall number Z-2280-2020
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: 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.
Published June 17, 2020 · Recall initiated: May 4, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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, Maryland, Tennessee, Oregon, Virginia, Iowa, Wisconsin, Louisiana, Georgia, Pennsylvania, North Dakota, Mississippi, South Dakota, Washington, Nebraska, Texas, Alaska, Puerto Rico, Idaho, Oregon, Maine, Vermont, West Virginia, Kansas.
- Lot
- Lot # 501874
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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