PRODUCT INFORMATION

Cat. No. LAL10565

399UL

Please note the concentration of Bicarbonate in 399UL – LAL10565 is high

approximately 24.1mmol/l similar to that of a normal QC. If you have any queries,

please contact Technical Services at technical.services@randox.com.

CCS INC1471

Page 1 of 1 FORM NO. 8373-GP

REVISION (2)
2 Aug 2019
ASSAYED LIQUID CHEMISTRY CONTROL LEVEL 1
CAT. NO. LAL10565 LOT NO. 399UL
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.

LIMITATIONS:
Bilirubin in the serum is light sensitive and it is recommended that the serum is stored in the dark. ALT, Alkaline Phosphatase,
Total and Direct Bilirubin and Lipase values may gradually decrease during the product’s shelf life. Bacterial contamination of the
thawed serum will cause reductions in the stability of many components. The control should not be used as a calibration
material. Due to the zinc content in some batches of rubber stoppers, the QC and calibrator material should be aliquoted into
polypropylene tubes and stored at +2°C to +8°C to ensure stable zinc levels throughout the stability period.

PAGE 1 OF 3
 LAL10565 – 399UL

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.

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 1 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
 LAL10565 – 399UL

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. 23 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 1
Lot. No: 399UL Cat. No: LAL10565 Expiry: 2026-08-28
Size: 12 x 4ml Range
Analyte Unit Target Low High 1SD 2SD Method
Albumin g/dl 2.38 2.02 2.74 0.180 0.360 Bromocresol Green
g/l 23.8 20.2 27.4 1.80 3.60
Alkaline Phosphatase U/l 43 37 49 3.00 6.00 AMP optimised to IFCC
Alpha-1-Antitrypsin g/l 0.336 0.269 0.403 0.034 0.067 Immunoturbidimetric
mg/dl 33.6 26.9 40.3 3.35 6.70
ALT (GPT) U/l 33 26 40 3.50 7.00 Tris Buffer With P5P
Amylase Pancreatic U/l 31 26 36 2.50 5.00 Immunoinhibition, EPS substrate
Amylase Total U/l 51 43 59 4.00 8.00 Siemens - blocked pNPG7
Apolipoprotein A1 g/l 0.765 0.627 0.903 0.069 0.138 Immunoturbidimetric
mg/dl 76.5 62.7 90.3 6.90 13.8
Apolipoprotein B g/l 0.371 0.304 0.438 0.034 0.067 Immunoturbidimetric
mg/dl 37.1 30.4 43.8 3.35 6.70
AST (GOT) U/l 39 31 47 4.00 8.00 Tris Buffer With P5P
Bicarbonate mmol/l 25.0 19.8 30.2 2.60 5.20 Enzymatic
Bilirubin Direct mg/dl 0.603 0.476 0.730 0.064 0.127 Oxidation to Biliverdin/Vanadate
µmol/l 10.3 8.14 12.5 1.10 2.20
Bilirubin Total mg/dl 1.15 0.909 1.39 0.120 0.240 Oxidation to Biliverdin/Vanadate
µmol/l 19.6 15.5 23.7 2.05 4.10
Calcium mg/dl 6.25 5.63 6.87 0.310 0.620 Arsenazo III
mmol/l 1.56 1.40 1.72 0.080 0.160
Carbamazepine µg/ml 4.47 3.58 5.36 0.445 0.890 Immunoturbidimetric
µmol/l 18.9 15.1 22.7 1.90 3.80
Cholesterol mg/dl 124 108 140 8.00 16.0 Cholesterol Oxidase - Abell Kendall
mmol/l 3.20 2.78 3.62 0.210 0.420
CK Total U/l 62 51 73 5.50 11.0 CK-NAC (IFCC)
Complement C3 g/l 0.666 0.533 0.799 0.067 0.133 Turbidimetric (IFCC Cal.)
mg/dl 66.6 53.3 79.9 6.65 13.3
Complement C4 g/l 0.120 0.096 0.144 0.012 0.024 Turbidimetric (IFCC Cal.)
mg/dl 12.0 9.60 14.4 1.20 2.40
Creatinine mg/dl 0.650 0.520 0.780 0.065 0.130 Jaffe rate blanked comp. (-26umol/l)
µmol/l 57.5 46.0 69.0 5.75 11.5
Digoxin ng/ml 1.27 1.02 1.52 0.125 0.250 Immunoturbidimetric
nmol/l 1.63 1.30 1.96 0.165 0.330
Ethanol (Alcohol) mmol/l 51.4 41.1 61.7 5.15 10.3 Enzymatic
gamma-GT U/l 28 24 32 2.00 4.00 Gamma glut'3-carb'4-nitro(IFCC)
Glucose mg/dl 50.8 43.2 58.4 3.80 7.60 Glucose Oxidase
mmol/l 2.82 2.40 3.24 0.210 0.420

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 1
Lot. No: 399UL Cat. No: LAL10565 Expiry: 2026-08-28
Size: 12 x 4ml Range
Analyte Unit Target Low High 1SD 2SD Method
Glucose mg/dl 49.4 42.0 56.8 3.70 7.40 Hexokinase
mmol/l 2.74 2.33 3.15 0.205 0.410
Haptoglobin g/l 0.573 0.458 0.688 0.058 0.115 Turbidimetric (IFCC Cal.)
mg/dl 57.3 45.8 68.8 5.75 11.5
HDL - Cholesterol mg/dl 50.6 43.0 58.2 3.80 7.60 Direct HDL, Clearance method
mmol/l 1.31 1.11 1.51 0.100 0.200
Immunoglobulin A g/l 1.11 0.833 1.39 0.140 0.280 Turbidimetric (IFCC Cal.)
mg/dl 111 83.3 139 14.0 28.0
Immunoglobulin G g/l 6.71 5.50 7.92 0.605 1.21 Turbidimetric (IFCC Cal.)
mg/dl 671 550 792 60.5 121
Immunoglobulin M g/l 0.445 0.356 0.534 0.045 0.089 Turbidimetric (IFCC Cal.)
mg/dl 44.5 35.6 53.4 4.45 8.90
Iron µg/dl 82.2 67.4 97.0 7.40 14.8 Colorimetric without ppt.
µmol/l 14.7 12.1 17.3 1.30 2.60
Lactate mg/dl 5.00 4.10 5.90 0.450 0.900 UV-LDH
mmol/l 0.555 0.455 0.655 0.050 0.100
LDL Cholesterol mg/dl 47.1 40.0 54.2 3.55 7.10 Selective Detergent Methods
mmol/l 1.22 1.04 1.40 0.090 0.180
Lipase U/l 20 16 24 2.00 4.00 Colorimetric Randox
Lithium mg/dl 0.354 0.312 0.396 0.021 0.042 Spectrophotometric
mmol/l 0.510 0.449 0.571 0.031 0.061
Magnesium mg/dl 1.22 1.07 1.37 0.075 0.150 Xylidyl Blue
mmol/l 0.502 0.442 0.562 0.030 0.060
Paracetamol mg/l 16.1 12.9 19.3 1.60 3.20 Siemens Atellica IM
mmol/l 0.106 0.085 0.127 0.011 0.021
Phenobarbital µg/ml 7.61 6.09 9.13 0.760 1.52 Immunoturbidimetric
µmol/l 32.8 26.2 39.4 3.30 6.60
Phenytoin µg/ml 6.16 4.93 7.39 0.615 1.23 Immunoturbidimetric
µmol/l 24.4 19.5 29.3 2.45 4.90
Phosphate Inorganic mg/dl 2.49 2.12 2.86 0.185 0.370 Phosphomolybdate UV
mmol/l 0.803 0.683 0.923 0.060 0.120
Prealbumin g/l 0.110 0.087 0.133 0.012 0.023 Turbidimetric (IFCC Cal.)
mg/dl 11.0 8.69 13.3 1.15 2.30
Protein Total g/dl 3.81 3.05 4.57 0.380 0.760 Biuret reaction, end point
g/l 38.1 30.5 45.7 3.80 7.60
Salicylate mg/dl 3.85 3.08 4.62 0.385 0.770 Colorimetric
mmol/l 0.279 0.223 0.335 0.028 0.056
Theophylline µg/ml 4.69 3.75 5.63 0.470 0.940 Immunoturbidimetric
µmol/l 26.0 20.8 31.2 2.60 5.20

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 1
Lot. No: 399UL Cat. No: LAL10565 Expiry: 2026-08-28
Size: 12 x 4ml Range
Analyte Unit Target Low High 1SD 2SD Method
TIBC µg/dl 178 141 215 18.5 37.0 Direct Colorimetric
µmol/l 31.9 25.2 38.6 3.35 6.70
Transferrin g/l 1.31 1.05 1.57 0.130 0.260 Turbidimetric (IFCC Cal.)
mg/dl 131 105 157 13.0 26.0
Triglycerides mg/dl 131 110 152 10.5 21.0 Lipase/GPO-PAP No Correction
mmol/l 1.48 1.24 1.72 0.120 0.240
Urea mg/dl 9.01 7.66 10.4 0.695 1.39 Urease, kinetic
mg/dl 4.20 3.57 4.83 0.315 0.630
(BUN)
mmol/l 1.50 1.28 1.72 0.110 0.220
Uric Acid (Urate) mg/dl 2.42 2.11 2.73 0.155 0.310 Uricase perox. no ascorb. ox.
mmol/l 0.144 0.125 0.163 0.010 0.019

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