FDA-Device2014-01-15Class II
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) 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
Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.
Sold states
Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.
Affected count
11006 Total
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clinical Systems. Dimension(R) Hemoglobin A1c (HB1C) Flex(R) reagent Cartridge on the Dimension(R) 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-0625-2014Don't want to check this manually?
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