PRODUCT INFORMATION

Cat. No. LAE10567

1401UE

Please note the concentration of Digoxin in 1401UE – LAE10567 is high

approximately 5ng/ml and may be outside the assay range of your instrument.

The concentration of DHEA-S is low in this control material at an approximate

concentration of 7.2 µmol/l and therefore not suitable to be used as an elevated QC.

If you have any queries, please contact Technical Services at

technical.services@randox.com.

CCS INC1222

Page 1 of 1 FORM NO. 8373-GP

REVISION (2)
2 Aug 2019
ASSAYED LIQUID CHEMISTRY CONTROL LEVEL 3
CAT. NO. LAE10567 LOT NO. 1401UE
SIZE: 12 x 4 ml EXPIRY: 2026-08-28

INTENDED USE
The Assayed Liquid Chemistry Controls are intended for the quantitative determination of alpha-HBDH, Acid Phosphatase (Total),
Albumin, Alkaline Phosphatase, Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alphafoetoprotein (AFP), ALT (GPT), Amikacin,
Amylase Pancreatic, Amylase Total, Apolipoprotein A-1, Apolipoprotein B, AST (GOT), Beta-2-microglobulin, Bicarbonate, Bile Acids,
Bilirubin Direct, Bilirubin Total, C-Reactive Protein, Ceruloplasmin, Caffeine, Calcium, Carbamazepine, Carcinoembryonic Antigen
(CEA), Chloride, Cholesterol, Cholinesterase, CK Total, Complement C3, Complement C4, Copper, Cortisol, Creatinine, D-3-
Hydroxybutyate, DHEA Sulphate, Digoxin, Ethanol, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, gamma-GT, GLDH, Glucose,
Haptoglobin, HDL – Cholesterol, Human Chorionic Gonadotrophin (hCG), Immunoglobulin A, Immunoglobulin E, Immunoglobulin G,
Immunoglobulin M, Iron, Lactate, Lactate Dehydrogenase (LDH), LDL-Cholesterol, Luteinising Hormone (LH), Lipase, Lipoprotein (a),
Lithium, Magnesium, Myoglobin, Osmolality, Paracetamol, Phenobarbital, Phenytoin, Phosphate Inorganic, Potassium, Prealbumin,
Progesterone, Prolactin, Protein Total, PSA Total, Salicylate, Sodium, Testosterone, Theophylline, Thyroid Stimulating Hormone, TIBC,
Total T3, Total T4, Transferrin, Triglycerides, Troponin T, T Uptake, Urea, Uric Acid (Urate), Valproic acid, Vancomycin, Vitamin B12,
Zinc. Assayed Liquid Chemistry Controls are assayed with target values and are suitable for use on automated analysers. Assayed
Liquid Chemistry Controls are for use by trained laboratory professionals and can be used in determining the precision of testing
systems and in identifying sources of variation.

FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.

DEVICE DESCRIPTION
The Assayed Liquid Chemistry Controls are supplied at 3 levels, level 1, 2 and 3. Target values and ranges are supplied for the analytes
listed in the values section.

SAFETY PRECAUTIONS AND WARNINGS

The Assayed Liquid Chemistry Controls are intended for in vitro use only. Do not pipette by mouth. Exercise the normal precautions
required for handling laboratory reagents and controls.

Human source material, which has been added, has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2)
antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and was found to be NON-REACTIVE. FDA
approved methods have been used to conduct these tests.

However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples
should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

Safety Data sheets are available on request.

If there is damage to the material upon arrival, the appearance is not as expected or the material is not performing as it should please
contact Randox Laboratories Technical Services, Northern Ireland, telephone +44 (0) 28 9445 1070 or email
technical.services@randox.com

STORAGE AND STABILITY

OPENED: Stored refrigerated (+2°C to +8°C). Controls stable for 7 days at +2°C to +8°C, if kept capped in original container and
free from contamination. PSA Total is stable for 5 days at +2°C to +8°C and Troponin T 3 days at +2°C to +8°C, if kept capped in
original container and free from contamination.

OPENED: Stored onboard (+2°C to +8°C). Controls stable for 7 days at +2°C to +8°C, if kept open onboard the instrument and free
from contamination. Ethanol and Bicarbonate are stable for 3 days at +2°C to +8°C, if kept open onboard the instrument and free
from contamination.

UNOPENED: Store frozen (-20°C to -80°C). Stable to expiration date printed on individual tubes.

PREPARATION FOR USE (REFRIGERATED +2°C to +8°C)

The Assayed Liquid Chemistry Controls are supplied liquid frozen ready for use.

1. Carefully remove required tubes from frozen storage and allow to stand for 30 minutes at +15°C to +25°C. Ensure contents are
completely thawed by swirling gently. Avoid the formation of foam. Do not shake the tube.
2. Remove the cap from the tube and place onboard the analyser for testing.
3. Refer to the Control section of the individual analyser application.
4. After testing is complete, promptly replace the cap on the tube and return the product to refrigerated storage and consult stability
claims above prior to reuse.
5. For optimal analyte stability minimise the time the product is onboard the instrument and exposed to room temperature
conditions.

PAGE 1 OF 3
 LAE10567 – 1401UE

PREPARATION FOR USE (ONBOARD STORAGE +2°C to +8°C)

The Assayed Liquid Chemistry Controls are supplied liquid frozen ready for use.

1. Carefully remove required tubes from frozen storage and allow to stand for 30 minutes at +15°C to +25°C. Ensure contents are
completely thawed by swirling gently. Avoid the formation of foam. Do not shake the tube.
2. Remove the cap from the tube and place onboard the analyser for storage and testing. The product should be stored open for the
duration of the onboard stability claim.
3. Refer to the Control section of the individual analyser application.
4. Consult the stability claims above prior to reuse.

MATERIALS PROVIDED
Assayed Liquid Chemistry Control Level 3 12 x 4 ml

MATERIALS REQUIRED BUT NOT PROVIDED

N/A

VALUE ASSIGNMENT
Values are assigned from internal testing conducted at Randox Laboratories Ltd. Due to the variation caused by test equipment, test
reagents and laboratory technique, the quoted ranges are provided for guidance. It is recommended that these ranges are used until
each laboratory has established its own ranges, based on individual laboratory requirements.

PAGE 2 OF 3
 LAE10567 – 1401UE

SYMBOL GLOSSARY
Randox Laboratories uses the following symbols, which may appear on the product labelling.

Symbol Description

Catalogue number

Batch code

Control

Use-by date

Manufacturer

Authorized representative in the

European Community

Consult IFU

In vitro diagnostic medical device

CE Marking

CE Marking with Notified Body

Prescription device (US only)

Temperature limit

Do not re-use

YY/MM/DD Date format (year/month/day)

UK CA mark

Keep away from sunlight

Biological risks

This way up

Caution

Do not use if package is damaged and

consult instructions for use

Rev. 22 Jan ’25 me

PAGE 3 OF 3
Table of Content
Siemens Atellica Solution 2

Page 1 of 4 2025/05/18

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens Atellica Solution Assayed Liquid Chemistry Control Level 3
Lot. No: 1401UE Cat. No: LAE10567 Expiry: 2026-08-28
Size: 12 x 4ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 5.65 4.80 6.50 0.425 0.850 Bromocresol Green
g/l 56.5 48.0 65.0 4.25 8.50
Alkaline Phosphatase U/l 242 206 278 18.0 36.0 AMP optimised to IFCC
Alpha-1-Antitrypsin g/l 1.34 1.07 1.61 0.135 0.270 Immunoturbidimetric
mg/dl 134 107 161 13.5 27.0
ALT (GPT) U/l 213 170 256 21.5 43.0 Tris Buffer With P5P
Amylase Pancreatic U/l 302 257 347 22.5 45.0 Immunoinhibition, EPS substrate
Amylase Total U/l 354 301 407 26.5 53.0 Siemens - blocked pNPG7
Apolipoprotein A1 g/l 1.88 1.54 2.22 0.170 0.340 Immunoturbidimetric
mg/dl 188 154 222 17.0 34.0
Apolipoprotein B g/l 0.983 0.806 1.16 0.089 0.177 Immunoturbidimetric
mg/dl 98.3 80.6 116 8.85 17.7
AST (GOT) U/l 194 155 233 19.5 39.0 Tris Buffer With P5P
Bicarbonate mmol/l 27.9 22.1 33.7 2.90 5.80 Enzymatic
Bilirubin Direct mg/dl 1.65 1.30 2.00 0.175 0.350 Oxidation to Biliverdin/Vanadate
µmol/l 28.2 22.3 34.1 2.95 5.90
Bilirubin Total mg/dl 5.35 4.23 6.47 0.560 1.12 Oxidation to Biliverdin/Vanadate
µmol/l 91.4 72.2 111 9.80 19.6
Calcium mg/dl 11.9 10.7 13.1 0.600 1.20 Arsenazo III
mmol/l 2.97 2.67 3.27 0.150 0.300
Carbamazepine µg/ml 12.4 9.92 14.9 1.25 2.50 Immunoturbidimetric
µmol/l 52.4 41.9 62.9 5.25 10.5
Cholesterol mg/dl 258 224 292 17.0 34.0 Cholesterol Oxidase - Abell Kendall
mmol/l 6.68 5.81 7.55 0.435 0.870
CK Total U/l 523 429 617 47.0 94.0 CK-NAC (IFCC)
Complement C3 g/l 1.76 1.41 2.11 0.175 0.350 Turbidimetric (IFCC Cal.)
mg/dl 176 141 211 17.5 35.0
Complement C4 g/l 0.317 0.254 0.380 0.032 0.063 Turbidimetric (IFCC Cal.)
mg/dl 31.7 25.4 38.0 3.15 6.30
Creatinine mg/dl 4.50 3.60 5.40 0.450 0.900 Jaffe rate blanked comp. (-26umol/l)
µmol/l 398 318 478 40.0 80.0
Ethanol (Alcohol) mmol/l 122 97.6 146 12.0 24.0 Enzymatic
gamma-GT U/l 177 150 204 13.5 27.0 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 328 279 377 24.5 49.0 Glucose Oxidase
mmol/l 18.2 15.5 20.9 1.35 2.70
mg/dl 321 273 369 24.0 48.0 Hexokinase
mmol/l 17.8 15.1 20.5 1.35 2.70

Page 2 of 4 2025/05/18

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens Atellica Solution Assayed Liquid Chemistry Control Level 3
Lot. No: 1401UE Cat. No: LAE10567 Expiry: 2026-08-28
Size: 12 x 4ml Range
Analyte Unit Target Low High 1SD 2SD Method
Haptoglobin g/l 1.44 1.15 1.73 0.145 0.290 Turbidimetric (IFCC Cal.)
mg/dl 144 115 173 14.5 29.0
HDL - Cholesterol mg/dl 99.6 84.7 115 7.70 15.4 Direct HDL, Clearance method
mmol/l 2.58 2.19 2.97 0.195 0.390
Immunoglobulin A g/l 2.75 2.06 3.44 0.345 0.690 Turbidimetric (IFCC Cal.)
mg/dl 275 206 344 34.5 69.0
Immunoglobulin G g/l 16.0 13.1 18.9 1.45 2.90 Turbidimetric (IFCC Cal.)
mg/dl 1600 1312 1888 144 288
Immunoglobulin M g/l 1.18 0.944 1.42 0.120 0.240 Turbidimetric (IFCC Cal.)
mg/dl 118 94.4 142 12.0 24.0
Iron µg/dl 202 166 238 18.0 36.0 Colorimetric without ppt.
µmol/l 36.2 29.7 42.7 3.25 6.50
Lactate mg/dl 51.1 41.9 60.3 4.60 9.20 UV-LDH
mmol/l 5.67 4.65 6.69 0.510 1.02
LDL Cholesterol mg/dl 117 99.5 135 9.00 18.0 Selective Detergent Methods
mmol/l 3.02 2.57 3.47 0.225 0.450
Lipase U/l 91 73 109 9.00 18.0 Colorimetric Randox
Lithium mg/dl 1.05 0.924 1.18 0.065 0.130 Spectrophotometric
mmol/l 1.51 1.33 1.69 0.090 0.180
Magnesium mg/dl 4.33 3.81 4.85 0.260 0.520 Xylidyl Blue
mmol/l 1.78 1.57 1.99 0.105 0.210
Paracetamol mg/l 159 127 191 16.0 32.0 Siemens Atellica IM
mmol/l 1.05 0.840 1.26 0.105 0.210
Phenobarbital µg/ml 46.2 37.0 55.4 4.60 9.20 Immunoturbidimetric
µmol/l 199 159 239 20.0 40.0
Phenytoin µg/ml 18.5 14.8 22.2 1.85 3.70 Immunoturbidimetric
µmol/l 73.3 58.6 88.0 7.35 14.7
Phosphate Inorganic mg/dl 6.66 5.66 7.66 0.500 1.00 Phosphomolybdate UV
mmol/l 2.15 1.83 2.47 0.160 0.320
Prealbumin g/l 0.330 0.261 0.399 0.035 0.069 Turbidimetric (IFCC Cal.)
mg/dl 33.0 26.1 39.9 3.45 6.90
Protein Total g/dl 9.04 7.23 10.9 0.930 1.86 Biuret reaction, end point
g/l 90.4 72.3 109 9.30 18.6
Salicylate mg/dl 42.0 33.6 50.4 4.20 8.40 Colorimetric
mmol/l 3.04 2.43 3.65 0.305 0.610
Theophylline µg/ml 29.0 23.2 34.8 2.90 5.80 Immunoturbidimetric
µmol/l 161 129 193 16.0 32.0
TIBC µg/dl 391 309 473 41.0 82.0 Direct Colorimetric
µmol/l 70.0 55.3 84.7 7.35 14.7

Page 3 of 4 2025/05/18

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated
Siemens Atellica Solution Assayed Liquid Chemistry Control Level 3
Lot. No: 1401UE Cat. No: LAE10567 Expiry: 2026-08-28
Size: 12 x 4ml Range
Analyte Unit Target Low High 1SD 2SD Method
Transferrin g/l 3.13 2.50 3.76 0.315 0.630 Turbidimetric (IFCC Cal.)
mg/dl 313 250 376 31.5 63.0
Triglycerides mg/dl 337 283 391 27.0 54.0 Lipase/GPO-PAP No Correction
mmol/l 3.81 3.20 4.42 0.305 0.610
Urea mg/dl 57.0 48.5 65.5 4.25 8.50 Urease, kinetic
mg/dl 26.5 22.5 30.5 2.00 4.00
(BUN)
mmol/l 9.48 8.06 10.9 0.710 1.42
Uric Acid (Urate) mg/dl 7.76 6.75 8.77 0.505 1.01 Uricase perox. no ascorb. ox.
mmol/l 0.462 0.402 0.522 0.030 0.060

Page 4 of 4 2025/05/18

Randox Laboratories Ltd., 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
Tel: Tel: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Email: Email: applications@randox.com Website: www.randox.com
All enzyme values are quoted to a temperature of 37°C, unless otherwise stated