eee 526 Route 303, Orangeburg NY 10962 INSTRUMENTATION LABORATORY CERTIFICATE OF UNCERTAINTY OF ASSIGNED VALUES This communication will certify the relative uncertainty of the assigned values of the parameters listed below. The Reference Material identity may be found in the respective TL Package Inserts The uncertainty was analyzed per ISO Standard 17511. A coverage factor of two is used. Immediately below is a flow chart of the traceability METROLOGICAL TRACEABILITY CHART HEMOSIL CALIBRATOR PLASMAS MATERIAL, PROCEDURE REFERENCE MATERIAL: INSTRUMENTATION WHO STANDARD OF LABORATORY SELECTED NORMAL DONOR POOL MEASUREMENT {@100 DONORS) PROCEDURE HOUSE STANDARD LOT (OF CALIBRATOR MATERIALAT fed INSTRUMENTATION LABORATORY INSTRUMENTATION LABORATORY SELECTED MEASUREMENT PROCEDURE PRODUCTION LOT AT INSTRUMENTATION |LABORATORY READY FOR ‘SALE TO CUSTOMERS Uncertainty calculation, in general: yeal=Assigned Calibration Plasma Value * ((2*SE IL Production Lot Calibration Plasma)*2+(2"SE IL House Standard)"2+ (2*SE WHO Standard)*2))*0.5.Table of Uncertainty for HemosIL. Calibration Plasma (PN 0020003700) Reagent, Part Number Parameter | U=2ptca RecombiPlasTin 2G (sec) (0020002950/ 0020003050 _| PT 0.054 RecombiPlasTin (sec) (0020002900/ 0020003000 _| PT 0.058 PT-Fibrinogen HS Plus (sec) (0008469810 PT, 0.078 PT-Fibrinogen (sec) (0009756710 PT 0.056 RecombiPlasTin 2G (mg/dL) (0020002950/ 0020003050 | PT-based Fib | 7.333 Fibrinogen HS Plus (mg/dl.) (0008469810 PT-based Fib | 7.094 Fibrinogen PT (mg/dL) (0009756710 PT-based Fib | 7.927 Fibrinogen-C (mg/dL) (00203011007 002003900 | Clauss Fib 3.201 APTT-SP (sec) (0020006300 APTT. 0.182, SynthASil (sec) ‘0020006800 APTI. Our Thrombin Time (3,0 UNIH/mL) (sec) | 0009758515 —[tt 0.118 Thrombin Time (1.9 UNIH/mL) (sec) | 0009758515 TT 0.197 Thrombin Time (7.5 UNIH/mL) (sec) | 0009758515 TT 0.051 [Factor II (%) (0020012200 Fil 1.480 Factor V (%) 0020011500 FV 1.280 Factor VII (%) (0020011700 F Vil 1.439 Factor X (%) (0020001000 FX L174 Factor VIII (%) (0020011800 Evil 2.611 Factor 1X (%) (0020011900 FIX 2.650 Factor XT(%) [0020011300 FXI 1.924 Factor XII (%) (0020011200 F XI 2304 Factor XIII Antigen (%) ‘0020201300 FXII 0.265 ro-IL-Complex (%) (0009758810 Pro-IL 1.348 Hepatocomplex (%) (0009758710 Hepato 1.568 “Antithrombin (Lig) (%) ‘0020002500700200301007 | AT 1.957 0020300400 it Plasminogen (%) ‘0020009000 Plasminogen | 1.696 Plasmin Inhibitor (%) ‘0020009200 Plasmin Inhibitor | 2.168 Prociot (%) (0008468310 PC 3.114 Protein C (%) (0020300500 PC 1.050 ProS (%) (0020002800 PS 2.374 Free Protein 5 (%) (0020002700 PS 1.254 VWE:AG (%) (0020002300 VWEAG 1.443 VWF Activity (%) (0020004700 VWF Activity [1.384 THE ABOVE IS CERTIFIED BY INSTRUMENTATION LABORATORY‘Table of Uncertainty for HemosIL D-Dimer Calibrators ‘Reagent Part Number Parameter U=2pe | D-Dimer (ng/mL) (0020008500 DD. 2.42 DD HS (ng/mL) 0020007700 DD AS 17.66 DD HS 500 (ngiml. FEU) (0020500100 DD HS 500 37.23 ‘Table of Uncertainty for HemosIL Liquid Heparin Calibrators (PN 0020300600) Reagent Part Number Parameter | U=2jta1 Liguid Hepain (0.0 TU/mL) (0020300600 Liguid Heparin | 0.008 Liquid Heparin (0.8 IU/mL) (0020300600 Liguid Heparin _ | 0.012 Liquid Heparin (2.0 IU/mL) (0020300600 Liguid Heparin [0.020 THE ABOVE IS CERTIFIED BY INSTRUMENTATION LABORATORYRESEARCH AND DEVELOPMENT PRINTED NAME‘TITLE: Ralph Bottenus / Director SIGNATURE: tk aby! BAS DATE; Bo 5 do QUALITY ASSURANCE PRINTED NAME/TITLE: Barbara Way / Director SIGNATURE: 42 peder ver Lf 77 DATE:__3- 9 = 201, MARKETING PRINTED NAME/TITLE: , Giovanni Russi / Director SIGNATURE: pae:__3- 3 £ Su