NOTE: This table will be discontinued after this lot.

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Transcription:

AS037-011 Rev. 11/14 ASSAY VALUES AND EXPECTED RANGES QCP DATA MONTHS: DEC, JAN, FEB Beckman Coulter STKS / MAXM / HMX LEVEL 1 + Lot No.: Exp. Date: LOT 871086 Parameter Mean Range WBC 10 3 /µl 4.0 ± 0.6 NE% % 54.0 ± 12.0 NE# 10 3 /µl 2.1 ± 0.5 NOTE: This table will be discontinued after this lot. LY% % 32.0 ± 10.0 LY# 10 3 /µl 1.3 ± 0.5 MO% % 5.0 ± 5.0 MO# 10 3 /µl 0.2 ± 0.2 EO% % 8.0 ± 8.0 EO# 10 3 /µl 0.3 ± 0.3 BA% % 1.0 ± 1.0 BA# 10 3 /µl 0.1 ± 0.1 RBC 10 6 /µl 2.53 ± 0.12 HGB g/dl 6.7 ± 0.4 HGB g/l 67 ± 4 HGB mmol/l 4.2 ± 0.3 HCT % 21.5 ± 1.5 HCT L/L 0.215 ± 0.015 MCV fl 85.0 ± 5.0 MCH pg 26.5 ± 1.8 MCH fmol 1.64 ± 0.11 MCHC g/dl 31.2 ± 2.4 MCHC g/l 312 ± 24 MCHC mmol/l 19.3 ± 2.3 RDW % 16.0 ± 5.0 PLT 10 3 /µl 80 ± 20 MPV fl 8.7 ± 2.0 * PCT % 0.070 ± 0.030 * PCT ml/l 0.7 ± 0.3 * PDW 16.5 ± 3.0 AS037-011 Rev. 11/14

AS037-011 Rev. 11/14 ASSAY VALUES AND EXPECTED RANGES QCP DATA MONTHS: DEC, JAN, FEB Beckman Coulter STKS / MAXM / HMX LEVEL 2 ++ Lot No.: Exp. Date: LOT 882086 Parameter Mean Range WBC 10 3 /µl 9.9 ± 1.5 NE% % 60.0 ± 12.0 NE# 10 3 /µl 5.9 ± 1.2 NOTE: This table will be discontinued after this lot. LY% % 25.0 ± 10.0 LY# 10 3 /µl 2.5 ± 1.1 MO% % 6.0 ± 6.0 MO# 10 3 /µl 0.6 ± 0.6 EO% % 8.0 ± 8.0 EO# 10 3 /µl 0.8 ± 0.8 BA% % 1.0 ± 1.0 BA# 10 3 /µl 0.1 ± 0.1 RBC 10 6 /µl 4.16 ± 0.18 HGB g/dl 12.1 ± 0.5 HGB g/l 121 ± 5 HGB mmol/l 7.5 ± 0.3 HCT % 38.9 ± 2.0 HCT L/L 0.389 ± 0.020 MCV fl 93.5 ± 5.0 MCH pg 29.1 ± 1.8 MCH fmol 1.80 ± 0.12 MCHC g/dl 31.1 ± 2.4 MCHC g/l 311 ± 24 MCHC mmol/l 19.3 ± 1.8 RDW % 15.0 ± 5.0 PLT 10 3 /µl 255 ± 50 MPV fl 8.6 ± 2.0 * PCT % 0.215 ± 0.050 * PCT ml/l 2.2 ± 0.5 * PDW 16.3 ± 3.0 AS037-011 Rev. 11/14

AS037-011 Rev. 11/14 ASSAY VALUES AND EXPECTED RANGES QCP DATA MONTHS: DEC, JAN, FEB Beckman Coulter STKS / MAXM / HMX LEVEL 3 +++ Lot No.: Exp. Date: LOT 863086 Parameter Mean Range WBC 10 3 /µl 21.8 ± 2.8 NE% % 68.0 ± 12.0 NE# 10 3 /µl 14.9 ± 2.7 NOTE: This table will be discontinued after this lot. LY% % 17.5 ± 10.0 LY# 10 3 /µl 3.8 ± 2.2 MO% % 8.0 ± 8.0 MO# 10 3 /µl 1.7 ± 1.7 EO% % 5.5 ± 5.5 EO# 10 3 /µl 1.2 ± 1.2 BA% % 1.0 ± 1.0 BA# 10 3 /µl 0.2 ± 0.2 RBC 10 6 /µl 5.45 ± 0.24 HGB g/dl 16.8 ± 0.8 HGB g/l 168 ± 8 HGB mmol/l 10.4 ± 0.5 HCT % 56.4 ± 2.8 HCT L/L 0.564 ± 0.028 MCV fl 103.5 ± 5.0 MCH pg 30.8 ± 1.8 MCH fmol 1.91 ± 0.16 MCHC g/dl 29.8 ± 2.4 MCHC g/l 298 ± 24 MCHC mmol/l 18.5 ± 1.8 RDW % 14.5 ± 5.0 PLT 10 3 /µl 445 ± 70 MPV fl 8.7 ± 2.0 * PCT % 0.380 ± 0.080 * PCT ml/l 3.8 ± 0.8 * PDW 16.2 ± 3.0 AS037-011 Rev. 11/14

ASSAY VALUES AND EXPECTED RANGES + Beckman Coulter UniCel DxH TM 800/600 QCP DATA MONTHS: DEC, JAN, FEB LEVEL 1 LEVEL 2 LEVEL 3 Lot No.: LOT 128710860 Lot No.: LOT 138820860 Lot No.: LOT 148630860 Parameter Mean Range Mean Range Mean Range WBC 10 3 /µl 4.0 ± 0.6 10.4 ± 1.5 22.4 ± 2.8 NE% % 66.0 ± 15.0 65.0 ± 15.0 66.0 ± 15.0 NE# 10 3 /µl 2.6 ± 0.6 6.7 ± 1.6 14.8 ± 3.4 LY% % 18.0 ± 13.0 14.0 ± 11.0 14.0 ± 10.0 LY# 10 3 /µl 0.7 ± 0.5 1.5 ± 1.2 3.1 ± 2.2 MO% % 4.0 ± 4.0 9.0 ± 9.0 12.0 ± 12.0 MO# 10 3 /µl 0.2 ± 0.2 0.9 ± 0.9 2.7 ± 2.7 EO% % 11.0 ± 11.0 10.5 ± 10.5 6.5 ± 6.5 EO# 10 3 /µl 0.4 ± 0.4 1.1 ± 1.1 1.5 ± 1.5 BA% % 1.0 ± 1.0 1.5 ± 1.5 1.5 ± 1.5 BA# 10 3 /µl 0.1 ± 0.1 0.2 ± 0.2 0.3 ± 0.3 RBC 10 6 /µl 2.53 ± 0.12 4.16 ± 0.18 5.45 ± 0.24 HGB g/dl 6.7 ± 0.4 12.1 ± 0.5 16.8 ± 0.8 HGB g/l 67 ± 4 121 ± 5 168 ± 8 HGB mmol/l 4.2 ± 0.3 7.5 ± 0.3 10.4 ± 0.5 HCT % 22.1 ± 1.5 40.1 ± 2.0 58.0 ± 2.8 HCT L/L 0.221 ± 0.015 0.401 ± 0.020 0.580 ± 0.028 MCV fl 87.5 ± 5.0 96.5 ± 5.0 106.5 ± 5.0 MCH pg 26.5 ± 1.8 29.1 ± 1.8 30.8 ± 1.8 MCH fmol 1.64 ± 0.11 1.80 ± 0.12 1.91 ± 0.16 MCHC g/dl 30.3 ± 2.4 30.1 ± 2.4 28.9 ± 2.4 MCHC g/l 303 ± 24 301 ± 24 289 ± 24 MCHC mmol/l 18.8 ± 2.3 18.7 ± 1.8 17.9 ± 1.8 RDW % 16.0 ± 5.0 15.0 ± 5.0 14.5 ± 5.0 RDW-SD fl 50.5 ± 10.0 52.5 ± 10.0 56.5 ± 10.0 PLT 10 3 /µl 80 ± 20 255 ± 50 445 ± 70 MPV fl 8.7 ± 2.0 8.6 ± 2.0 8.7 ± 2.0 * PCT % 0.070 ± 0.030 0.215 ± 0.050 0.380 ± 0.080 * PCT ml/l 0.7 ± 0.3 2.2 ± 0.5 3.8 ± 0.8 * PDW 16.5 ± 3.0 16.3 ± 3.0 16.2 ± 3.0

NOTE: This table will be discontinued after this lot. ASSAY VALUES AND EXPECTED RANGES ++ Beckman Coulter GEN S TM QCP DATA MONTHS: DEC, JAN, FEB LEVEL 1 LEVEL 2 LEVEL 3 Lot No.: LOT 871086 Lot No.: LOT 882086 Lot No.: LOT 863086 Parameter Mean Range Mean Range Mean Range WBC 10 3 /µl 3.9 ± 0.6 9.9 ± 1.5 21.3 ± 2.8 NE% % 55.0 ± 12.0 60.5 ± 12.0 69.0 ± 12.0 NE# 10 3 /µl 2.1 ± 0.5 6.0 ± 1.2 14.7 ± 2.6 LY% % 34.0 ± 10.0 28.0 ± 10.0 21.0 ± 10.0 LY# 10 3 /µl 1.3 ± 0.4 2.8 ± 1.1 4.5 ± 2.2 MO% % 2.0 ± 2.0 3.0 ± 3.0 4.0 ± 4.0 MO# 10 3 /µl 0.1 ± 0.1 0.3 ± 0.3 0.8 ± 0.8 EO% % 8.0 ± 8.0 7.5 ± 7.5 5.0 ± 5.0 EO# 10 3 /µl 0.3 ± 0.3 0.7 ± 0.7 1.1 ± 1.1 BA% % 1.0 ± 1.0 1.0 ± 1.0 1.0 ± 1.0 BA# 10 3 /µl 0.1 ± 0.1 0.1 ± 0.1 0.2 ± 0.2 RBC 10 6 /µl 2.53 ± 0.12 4.16 ± 0.18 5.45 ± 0.24 HGB g/dl 6.7 ± 0.4 12.1 ± 0.5 16.8 ± 0.8 HGB g/l 67 ± 4 121 ± 5 168 ± 8 HGB mmol/l 4.2 ± 0.3 7.5 ± 0.3 10.4 ± 0.5 HCT % 21.5 ± 1.5 38.9 ± 2.0 56.4 ± 2.8 HCT L/L 0.215 ± 0.015 0.389 ± 0.020 0.564 ± 0.028 MCV fl 85.0 ± 5.0 93.5 ± 5.0 103.5 ± 5.0 MCH pg 26.5 ± 1.8 29.1 ± 1.8 30.8 ± 1.8 MCH fmol 1.64 ± 0.11 1.80 ± 0.12 1.91 ± 0.16 MCHC g/dl 31.2 ± 2.4 31.1 ± 2.4 29.8 ± 2.4 MCHC g/l 312 ± 24 311 ± 24 298 ± 24 MCHC mmol/l 19.3 ± 2.3 19.3 ± 1.8 18.5 ± 1.8 RDW % 16.0 ± 5.0 15.0 ± 5.0 14.5 ± 5.0 PLT 10 3 /µl 80 ± 20 255 ± 50 445 ± 70 MPV fl 8.7 ± 2.0 8.6 ± 2.0 8.7 ± 2.0 * PCT % 0.070 ± 0.030 0.215 ± 0.050 0.380 ± 0.080 * PCT ml/l 0.7 ± 0.3 2.2 ± 0.5 3.8 ± 0.8 * PDW 16.5 ± 3.0 16.3 ± 3.0 16.2 ± 3.0

ASSAY VALUES AND EXPECTED RANGES +++ Beckman Coulter LH 700 Series QCP DATA MONTHS: DEC, JAN, FEB LEVEL 1 LEVEL 2 LEVEL 3 Lot No.: LOT 871086 Lot No.: LOT 882086 Lot No.: LOT 863086 Parameter Mean Range Mean Range Mean Range WBC 10 3 /µl 3.9 ± 0.6 9.9 ± 1.5 21.3 ± 2.8 NE% % 54.5 ± 12.0 60.5 ± 12.0 69.0 ± 12.0 NE# 10 3 /µl 2.1 ± 0.5 6.0 ± 1.2 14.7 ± 2.6 LY% % 32.0 ± 10.0 25.0 ± 10.0 17.5 ± 10.0 LY# 10 3 /µl 1.2 ± 0.4 2.5 ± 1.1 3.7 ± 2.2 MO% % 5.0 ± 5.0 6.0 ± 6.0 7.5 ± 7.5 MO# 10 3 /µl 0.2 ± 0.2 0.6 ± 0.6 1.6 ± 1.6 EO% % 7.5 ± 7.5 7.5 ± 7.5 5.0 ± 5.0 EO# 10 3 /µl 0.3 ± 0.3 0.7 ± 0.7 1.1 ± 1.1 BA% % 1.0 ± 1.0 1.0 ± 1.0 1.0 ± 1.0 BA# 10 3 /µl 0.1 ± 0.1 0.1 ± 0.1 0.2 ± 0.2 RBC 10 6 /µl 2.53 ± 0.12 4.16 ± 0.18 5.45 ± 0.24 HGB g/dl 6.7 ± 0.4 12.1 ± 0.5 16.8 ± 0.8 HGB g/l 67 ± 4 121 ± 5 168 ± 8 HGB mmol/l 4.2 ± 0.3 7.5 ± 0.3 10.4 ± 0.5 HCT % 21.5 ± 1.5 38.9 ± 2.0 56.4 ± 2.8 HCT L/L 0.215 ± 0.015 0.389 ± 0.020 0.564 ± 0.028 MCV fl 85.0 ± 5.0 93.5 ± 5.0 103.5 ± 5.0 MCH pg 26.5 ± 1.8 29.1 ± 1.8 30.8 ± 1.8 MCH fmol 1.64 ± 0.11 1.80 ± 0.12 1.91 ± 0.16 MCHC g/dl 31.2 ± 2.4 31.1 ± 2.4 29.8 ± 2.4 MCHC g/l 312 ± 24 311 ± 24 298 ± 24 MCHC mmol/l 19.3 ± 2.3 19.3 ± 1.8 18.5 ± 1.8 RDW % 16.0 ± 5.0 15.0 ± 5.0 14.5 ± 5.0 * RDW-SD fl 50.5 ± 10.0 52.5 ± 10.0 56.5 ± 10.0 PLT 10 3 /µl 80 ± 20 255 ± 50 445 ± 70 MPV fl 8.7 ± 2.0 8.6 ± 2.0 8.7 ± 2.0 ** PCT % 0.070 ± 0.030 0.215 ± 0.050 0.380 ± 0.080 ** PCT ml/l 0.7 ± 0.3 2.2 ± 0.5 3.8 ± 0.8 ** PDW 16.5 ± 3.0 16.3 ± 3.0 16.2 ± 3.0 * For Coulter LH 780 Only *

ASSAY VALUES AND EXPECTED RANGES ++++ Beckman Coulter LH 500 QCP DATA MONTHS: DEC, JAN, FEB LEVEL 1 LEVEL 2 LEVEL 3 Lot No.: LOT 871086 Lot No.: LOT 882086 Lot No.: LOT 863086 Parameter Mean Range Mean Range Mean Range WBC 10 3 /µl 3.9 ± 0.6 9.9 ± 1.5 21.3 ± 2.8 NE% % 49.5 ± 12.0 55.0 ± 12.0 64.0 ± 12.0 NE# 10 3 /µl 1.9 ± 0.5 5.5 ± 1.3 13.7 ± 2.6 LY% % 35.5 ± 14.0 26.5 ± 10.0 17.5 ± 10.0 LY# 10 3 /µl 1.4 ± 0.6 2.6 ± 1.0 3.7 ± 2.2 MO% % 4.0 ± 4.0 7.5 ± 7.5 10.0 ± 10.0 MO# 10 3 /µl 0.2 ± 0.2 0.7 ± 0.7 2.1 ± 2.1 EO% % 8.0 ± 8.0 8.0 ± 8.0 5.5 ± 5.5 EO# 10 3 /µl 0.3 ± 0.3 0.8 ± 0.8 1.2 ± 1.2 BA% % 3.0 ± 3.0 3.0 ± 3.0 3.0 ± 3.0 BA# 10 3 /µl 0.1 ± 0.1 0.3 ± 0.3 0.6 ± 0.6 RBC 10 6 /µl 2.53 ± 0.12 4.16 ± 0.18 5.45 ± 0.24 HGB g/dl 6.7 ± 0.4 12.1 ± 0.5 16.8 ± 0.8 HGB g/l 67 ± 4 121 ± 5 168 ± 8 HGB mmol/l 4.2 ± 0.3 7.5 ± 0.3 10.4 ± 0.5 HCT % 21.5 ± 1.5 38.9 ± 2.0 56.4 ± 2.8 HCT L/L 0.215 ± 0.015 0.389 ± 0.020 0.564 ± 0.028 MCV fl 85.0 ± 5.0 93.5 ± 5.0 103.5 ± 5.0 MCH pg 26.5 ± 1.8 29.1 ± 1.8 30.8 ± 1.8 MCH fmol 1.64 ± 0.11 1.80 ± 0.12 1.91 ± 0.16 MCHC g/dl 31.2 ± 2.4 31.1 ± 2.4 29.8 ± 2.4 MCHC g/l 312 ± 24 311 ± 24 298 ± 24 MCHC mmol/l 19.3 ± 2.3 19.3 ± 1.8 18.5 ± 1.8 RDW % 16.0 ± 5.0 15.0 ± 5.0 14.5 ± 5.0 PLT 10 3 /µl 80 ± 20 255 ± 50 445 ± 70 MPV fl 8.7 ± 2.0 8.6 ± 2.0 8.7 ± 2.0 * PCT % 0.070 ± 0.030 0.215 ± 0.050 0.380 ± 0.080 * PCT ml/l 0.7 ± 0.3 2.2 ± 0.5 3.8 ± 0.8 * PDW 16.5 ± 3.0 16.3 ± 3.0 16.2 ± 3.0

LOT DxH 800 Only 871086 12 871086 0 882086 13 882086 0 863086 14 863086 0 +++++ Beckman Coulter UniCel DxH 800/600 Beckman Coulter LH 750 Series Beckman Coulter LH 780 Series Beckman Coulter LH 500