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.

Reason: Positive bias on the lots listed compared to alternate methods and a higher frequency of "Above Assay Range" flags with the lots listed.

Code information: Catalog number DF105A (Siemens Material Number 10483822) - Lot numbers GA3099, exp. 4/9/13; GA3141, exp. 5/21/13; GA3197, exp. 7/16/13; GA3247, exp. 9/4/13; GA3113, exp. 4/23/13; GA3162, exp. 6/11/13; GB3211, exp. 7/30/13; GA3267, exp. 9/24/13; GA3134, exp. 5/14/13; GA3169, exp. 6/18/13; GA3232, exp. 8/20/13; GB3281, exp. 10/8/13, GC3302, exp. 10/29/13.

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada and Mexico.