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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 LABORATORYRESEARCH 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
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pae:__3- 3 £ Su