XCAL™

XE-SERIES ASSAY
FSR USE ONLY This Product Must Be Run In Service Mode, Control 3

Lot Number 31360557 Exp. Date 2023-06-18

Effective Date: OPEN MODE Targets and Limits

PLT-Blood WBC# WBC#
17-May-23 WBC RBC HGB PLT
Bank
PLT-O RBC-O* RETIC% IMI#*
(DIFF)* (NRBC)*
Target 7.78 4.37 12.2 253 266 245 4.38 3.14 3273 7.10 7.27
Lower Limit 7.55 4.28 12.0 241 253 228 4.17 2.89 3024 6.89 6.92
Upper Limit 8.01 4.46 12.4 265 279 262 4.59 3.39 3522 7.31 7.62

CLOSED MODE Targets and Limits

PLT-Blood WBC# WBC#
17-May-23 WBC RBC HGB HCT MCV PLT
Bank
PLT-O RBC-O* IMI#*
(DIFF)* (NRBC)*
Target 7.31 4.37 12.2 35.4 80.9 251 263 243 4.38 3273 6.89 7.27
Lower Limit 7.01 4.28 11.9 34.2 78.5 240 252 226 4.19 3024 6.54 6.77
Upper Limit 7.61 4.46 12.5 36.6 83.3 262 274 260 4.57 3522 7.24 7.77

DCP Targets and Limits

Effective Date:

17-May-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* NRBC-X* RBC-X* RBC-Y* IMI-DC* IMI-RF* RBC-HE* HCT MCV Use Between:
Target 153.3 62.8 108.8 132.3 177.5 25.8 165.2 516.0 188.4 28.4 35.2 80.5 17-May-23
Lower Limit 151.9 59.8 106.8 129.3 174.8 24.3 162.6 505.7 179.4 27.0 34.2 78.5 30-May-23
Upper Limit 154.7 65.8 110.8 135.3 180.2 27.3 167.8 526.3 197.4 29.8 36.2 82.5

Effective Date:

31-May-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* NRBC-X* RBC-X* RBC-Y* IMI-DC* IMI-RF* RBC-HE* HCT MCV Use Between:
Target 153.3 61.5 108.8 132.3 177.5 25.7 165.2 516.0 188.4 28.4 35.4 80.9 31-May-23
Lower Limit 151.9 58.5 106.8 129.3 174.8 24.2 162.6 505.7 179.4 27.0 34.4 78.9 09-Jun-23
Upper Limit 154.7 64.5 110.8 135.3 180.2 27.2 167.8 526.3 197.4 29.8 36.4 82.9

Effective Date:

10-Jun-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* NRBC-X* RBC-X* RBC-Y* IMI-DC* IMI-RF* RBC-HE* HCT MCV Use Between:
Target 153.3 60.2 108.8 132.3 177.5 25.7 165.2 516.0 188.4 28.4 35.5 81.2 10-Jun-23
Lower Limit 151.9 57.2 106.8 129.3 174.8 24.2 162.6 505.7 179.4 27.0 34.5 79.2 18-Jun-23
Upper Limit 154.7 63.2 110.8 135.3 180.2 27.2 167.8 526.3 197.4 29.8 36.5 83.2
*Detector Control Parameters (DCP) are non-reportable parameters for internal use only used by Service Personnel.

Distributed by: 350420

Sysmex America, Inc. Rev 12. 10-Jan-2019
Lincolnshire, IL May-23

XCAL™
XT-SERIES ASSAY
FSR USE ONLY This Product Must Be Run In Service Mode, Control 3

Lot Number 31360557 Exp. Date 2023-06-18

Effective Date: OPEN MODE Targets and Limits

WBC#
17-May-23 WBC RBC HGB PLT PLT-O* RBC-O* RETIC%
(DIFF)*
Target 7.85 4.40 12.0 251 220 4.33 2.58 6.95
Lower Limit 7.62 4.31 11.8 239 203 4.16 2.33 6.71
Upper Limit 8.08 4.49 12.2 263 237 4.50 2.83 7.19

CLOSED MODE Targets and Limits

WBC#
17-May-23 WBC RBC HGB HCT MCV PLT PLT-O* RBC-O*
(DIFF)*
Target 7.46 4.40 12.0 36.0 81.9 244 220 4.44 7.16
Lower Limit 7.16 4.31 11.7 34.8 79.5 233 203 4.27 6.76
Upper Limit 7.76 4.49 12.3 37.2 84.3 255 237 4.61 7.56

DCP Targets and Limits

Effective Date:

17-May-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* RBC-X* RBC-Y* MPV RBC-HE* HCT MCV Use Between:
Target 160.4 67.8 117.4 138.8 25.4 158.8 9.4 27.5 35.8 81.5 17-May-23
Lower Limit 157.8 64.8 114.4 136.0 24.1 155.5 9.0 26.1 34.8 79.5 30-May-23
Upper Limit 162.1 70.8 120.4 141.6 26.7 162.1 9.8 28.9 36.8 83.5

Effective Date:

31-May-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* RBC-X* RBC-Y* MPV RBC-HE* HCT MCV Use Between:
Target 160.4 66.1 117.4 138.8 25.4 158.8 9.4 27.5 36.0 81.9 31-May-23
Lower Limit 157.8 63.1 114.4 136.0 24.1 155.5 9.0 26.1 35.0 79.9 09-Jun-23
Upper Limit 162.1 69.1 120.4 141.6 26.7 162.1 9.8 28.9 37.0 83.9

Effective Date:

10-Jun-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* RBC-X* RBC-Y* MPV RBC-HE* HCT MCV Use Between:
Target 160.4 64.3 117.4 138.8 25.4 158.8 9.4 27.5 36.1 82.1 10-Jun-23
Lower Limit 157.8 61.3 114.4 136.0 24.1 155.5 9.0 26.1 35.1 80.1 18-Jun-23
Upper Limit 162.1 67.3 120.4 141.6 26.7 162.1 9.8 28.9 37.1 84.1
*Detector Control Parameters (DCP) are non-reportable parameters for internal use only used by Service Personnel.

Distributed by: 350420

Sysmex America, Inc. Rev 12. 10-Jan-2019
Lincolnshire, IL May-23
 XCAL™
XS-SERIES ASSAY
FSR USE ONLY This Product Must Be Run In Service Mode, Control 3

Lot Number 31360557 Exp. Date 2023-06-18

Effective Date: XS-1000i Analyzers

17-May-23 WBC-C WBC-D RBC HGB PLT MPV
Target 7.68 7.46 4.36 12.1 244 9.2
Lower Limit 7.46 7.25 4.27 11.9 232 8.8
Upper Limit 7.90 7.67 4.45 12.3 256 9.6

XS-1000i C Analyzers
17-May-23 WBC-C WBC-D RBC HGB PLT MPV
Target 7.69 7.41 4.36 12.0 246 9.7
Lower Limit 7.47 7.20 4.27 11.8 234 9.3
Upper Limit 7.91 7.62 4.45 12.2 258 10.1

Effective Date:                           XS-Series Analyzers Effective Date:                           XS-C Series Analyzers

17-May-23 DIFF-X* DIFF-Y* FSC-X* HCT MCV 17-May-23 DIFF-X* DIFF-Y* FSC-X* HCT MCV Use Between:

Target 165.7 58.1 27.1 35.7 81.9 Target 167.3 58.3 27.8 36.2 83.0 17-May-23
Lower Limit 163.1 55.1 26.1 34.7 79.9 Lower Limit 164.7 55.3 26.8 35.2 81.0 30-May-23
Upper Limit 168.3 61.1 28.1 36.7 83.9 Upper Limit 169.9 61.3 28.8 37.2 85.0

Effective Date:                            Effective Date:                           

31-May-23 DIFF-X* DIFF-Y* FSC-X* HCT MCV 31-May-23 DIFF-X* DIFF-Y* FSC-X* HCT MCV Use Between:

Target 165.7 56.9 27.1 35.9 82.3 Target 167.3 57.0 27.8 36.4 83.4 31-May-23
Lower Limit 163.1 53.9 26.1 34.9 80.3 Lower Limit 164.7 54.0 26.8 35.4 81.4 09-Jun-23
Upper Limit 168.3 59.9 28.1 36.9 84.3 Upper Limit 169.9 60.0 28.8 37.4 85.4

Effective Date:                            Effective Date:                           

10-Jun-23 DIFF-X* DIFF-Y* FSC-X* HCT MCV 10-Jun-23 DIFF-X* DIFF-Y* FSC-X* HCT MCV Use Between:

Target 165.7 55.6 27.1 36.0 82.5 Target 167.3 55.8 27.8 36.5 83.7 10-Jun-23
Lower Limit 163.1 52.6 26.1 35.0 80.5 Lower Limit 164.7 52.8 26.8 35.5 81.7 18-Jun-23
Upper Limit 168.3 58.6 28.1 37.0 84.5 Upper Limit 169.9 58.8 28.8 37.5 85.7
*Detector Control Parameters (DCP) are non-reportable parameters for internal use only used by Service Personnel.

Distributed by: 350420

Sysmex America, Inc. Rev 12. 10-Jan-2019
Lincolnshire, IL May-23

XCAL™
XE-C SERIES ASSAY
FSR USE ONLY This Product Must Be Run In Service Mode, Control 3

Lot Number 31360557 Exp. Date 2023-06-18

Effective Date: OPEN MODE Targets and Limits

WBC# WBC#
17-May-23 WBC RBC HGB PLT PLT-O RBC-O* RETIC% IMI#*
(DIFF)* (NRBC)*
Target 7.80 4.33 12.1 261 239 4.36 2.87 3273 7.14 7.35
Lower Limit 7.50 4.24 11.8 250 222 4.17 2.57 3024 6.79 7.00
Upper Limit 8.10 4.42 12.4 272 256 4.55 3.17 3522 7.49 7.70

CLOSED MODE Targets and Limits

WBC# WBC#
17-May-23 WBC RBC HGB HCT MCV PLT PLT-O RBC-O* IMI#*
(DIFF)* (NRBC)*
Target 7.33 4.33 12.1 33.8 78.1 259 237 4.36 3273 6.93 7.35
Lower Limit 7.03 4.24 11.8 32.6 75.7 248 220 4.17 3024 6.58 6.85
Upper Limit 7.63 4.42 12.4 35.0 80.5 270 254 4.55 3522 7.28 7.85

DCP Targets and Limits

Effective Date:

17-May-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* NRBC-X* RBC-X* RBC-Y* IMI-DC* IMI-RF* RBC-HE* HCT MCV Use Between:
Target 153.3 62.8 108.8 132.3 177.5 25.8 165.2 516.0 188.4 28.0 33.7 77.7 17-May-23
Lower Limit 150.3 58.2 105.5 129.6 173.9 24.2 161.9 505.7 179.4 26.6 32.7 75.7 30-May-23
Upper Limit 156.3 67.4 112.1 135.0 181.1 27.4 168.5 526.3 197.4 29.4 34.7 79.7

Effective Date:

31-May-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* NRBC-X* RBC-X* RBC-Y* IMI-DC* IMI-RF* RBC-HE* HCT MCV Use Between:
Target 153.3 61.5 108.8 132.3 177.5 25.7 165.2 516.0 188.4 28.0 33.5 77.3 31-May-23
Lower Limit 150.3 56.9 105.5 129.6 173.9 24.1 161.9 505.7 179.4 26.6 32.5 75.3 09-Jun-23
Upper Limit 156.3 66.1 112.1 135.0 181.1 27.3 168.5 526.3 197.4 29.4 34.5 79.3

Effective Date:

10-Jun-23 DIFF-X* DIFF-Y* BASO-X* BASO-Y* NRBC-X* RBC-X* RBC-Y* IMI-DC* IMI-RF* RBC-HE* HCT MCV Use Between:
Target 153.3 60.2 108.8 132.3 177.5 25.7 165.2 516.0 188.4 28.0 33.6 77.6 10-Jun-23
Lower Limit 150.3 55.6 105.5 129.6 173.9 24.1 161.9 505.7 179.4 26.6 32.6 75.6 18-Jun-23
Upper Limit 156.3 64.8 112.1 135.0 181.1 27.3 168.5 526.3 197.4 29.4 34.6 79.6
*Detector Control Parameters (DCP) are non-reportable parameters for internal use only used by Service Personnel.

Distributed by: 350420

Sysmex America, Inc. Rev 12. 10-Jan-2019
Lincolnshire, IL May-23