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.
Reported: June 17, 2020 Initiated: May 4, 2020 #Z-2280-2020
Product Description
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.
Reason for Recall
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 5
- Distribution
- 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.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 5.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2280-2020.
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