FDASeptember 22, 2020device

ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

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

The hazard

Fructosamine QC and patient samples may exhibit a 60 umol/L positive bias across the measuring range compared to predicate assay reference leading to a potential adjustment of hyperglycemic therapy. Positively biased fructosamine results may prompt changes in glucose management that may affect glycemia. In extreme situations, more aggressive management of glycemia may occur and contribute to hypoglycemia.

What to do

FDA enforcement status: Ongoing

Brands named

siemens healthcare diagnosticssiemenssiemens healthcare

UPCs

00630414558073

Recall history

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

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