FDAFDA · Food and drugs·Recall number Z-0101-2021
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
Published October 21, 2020 · Recall initiated: September 22, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- 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¿¿¿¿¿¿¿¿
- Lot
- All lots UDI: (01)00630414558073(10)501874(17)20201128 (01)00630414558073(10)514594(17)20210221 (01)00630414558073(10)528971(17)20210630
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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