FDA-Device2014-12-03Class II
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Siemens Healthcare Diagnostics, Inc.
Hazard
Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP). QC samples may exhibit a similar bias.
Sold states
Worldwide Distribution: US (nationwide) and internationally to: Canada.
Affected count
53, 046
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0420-2015Don't want to check this manually?
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