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FDAMay 4, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414595580

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear