FDA-Device2015-12-02Class II
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
Siemens Healthcare Diagnostics, Inc.
Hazard
Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples may exhibit a similar bias.
Sold states
Distributed in the states of AZ, NY, CA, IN, LA, MN, OH, MI, NM, and GA, and the countries of Mexico and Canada.
Affected count
3031
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0340-2016Don't want to check this manually?
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