Atellica CH 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): 11097637
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics is recalling Atellica CH Systems Fructosamine test kits used to measure glycated protein levels in blood samples. The fructosamine measurements from these kits may read 60 umol/L higher than they should be across the entire measuring range. This positive bias in results could lead healthcare providers to make adjustments to patient diabetes therapy based on inaccurately high readings. In some cases, this could result in overly aggressive glucose management and potentially cause dangerously low blood sugar levels (hypoglycemia). The recalled units were distributed in several U.S. states and numerous countries internationally, affecting 28 units in the U.S. and 255 units outside the U.S.
The recall affects all lots with the following UDI codes: (01)00630414595580(10)201115(17)20210201 and (01)00630414595580(10)201207(17)20210601. The source document does not specify a remedy or recommended action for affected consumers.
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: 28; OUS: 255 units Lot/code info: All lots UDI: (01)00630414595580(10)201115(17)20210201 (01)00630414595580(10)201207(17)20210601
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.