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
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Systems used to measure fructosamine (a marker of blood sugar control) because test results may show artificially high readings—up to 60 umol/L higher than the correct value. These falsely elevated results could lead doctors to make unnecessary changes to patients' diabetes treatment plans, potentially causing overly aggressive glucose management that could result in dangerously low blood sugar levels.
The recall affects 23 units distributed in the U.S. (California, Delaware, Maryland, North Carolina, New Jersey, New York, and Pennsylvania) and 204 units distributed internationally across multiple countries. The recall involves specific lot codes identified by UDI numbers. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: CA, DE, MD, NC, NJ, NY, PA Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Brazil¿¿¿¿ Canada¿¿¿¿¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ P.R.¿China¿¿¿¿¿ Paraguay¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vietnam¿¿¿¿¿¿¿¿ Quantity: US: 23 units; OUS: 204 units Lot/code info: All lots UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221 (01)00630414558073(10)528971(17)20210630
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.