H18 Control Package
Insert
Lot.
No.
Par 0 Lot.
t
No. No.
LOT:B0 High Lot
LOT:B0225L 225N B0225H
Expires: 5/1/2026 5/1/2026 5/1/2026
Gap Gap
Parameter Assay Gap (±) Assay (±) Assay (±)
WBC 2.1 ± 0.4 4.5 ± 0.7 19.9 ± 2.5
RBC 2.47 ± 0.20 4.7 ± 0.30 4.88 ± 0.40
HGB 5.8 ± 0.5 12.3 ± 0.7 15.9 ± 0.8
HCT 18.0 ± 2.5 36.5 ± 3.0 46.4 ± 4.0
MCV 73 6.0 72 ± 7.0 95 ± 7.0
MCH 23.5 ± 2.6 22.6 ± 3.0 32.6 ± 3.
MCHC 32.2 ± 3.5 32.4 5 34.3 ± 3.0
285
PLT 66 ± 25. 40 545 ± 70
LPCR 15.0 5.0 33.5 4 67.4
PCT 0.10 ± 0.06 0.17 0.1 0.68 ± 0.20
MPV 11.5 ± 3.0 10.6 ± 4.0 12.4 ± 4.0
PDW 36.9 ± 12.0 36.6 ± 6.0 34.8 ± 4.0
RDW 19.2 ± 5.0 13 ± 5.0 15.4 ± 5.0
LYM% 45 ± 0.5 23 ±8 11.6 16
MID% 2 ± 0.4 8.5 ±6 0.8 31
Gran% 55 ± 0.9 70 ± 10 7.5 52
.
FOR CALIBRATION
Normal Level Control
LOT #91642
Please use the assay table below for instrument
calibration (when the default choice MCV & MPV
calibration is selected).
Control Parameter Assay Units
RBC 4.24 M/µl
MCV 87 fl
RDWc 16.2 %
PLT 250 K/µl
MPV 11.0 fl
HGB 12.1 g/dl
WBC 8.3 K/µl
EOS 4.5 K/µl
Doc No. 770-7042 Rev C
SFRI – Lieu dit Berganton -33127 St Jean d’illac - France
SFRi H18 Hematology Controls
INTENDED USE
SFRi H18 controls are intended for use with the SFRi 2 Hold the tube/vial between the thumb and forefinger to mix.
H18 Hematology Systems. SFRi H18 normal control DO NOT PRE-MIX ON A MECHANICAL MIXER.
serves as both as an instrument calibrator to confirm 2a Slowly invert the tube/vial back and forth for 20-30
factory calibration and as quality control material. Refer seconds; Mix thoroughly, but do not shake.
to the next page for instructions on handling the
2b Continue to mix in this manner until the red cells are
calibrator.
completely suspended. Tubes/vials stored for a long
SUMMARY AND PRINCIPLE time may require extra mixing.
It is an established laboratory practice to use a stable 2c Gently invert the tube/vial 8-10 times immediately
control to monitor the performance of diagnostic tests. before sampling.
This control is composed of stable materials that provide 3 Analyze the sample as instructed in the Calibration or
a means of monitoring the performance of hematology Quality Control section of the Operator’s Manual for your
cell counters. It is sampled in the same manner as a 4 After Sampling:
patient specimen. 4a If tube/vial has been open for sampling, clean residual
REAGENTS material from the cap and tube rim with a lint-free
HM5 Low, Normal or High controls are in vitro tissue. Replace the cap tightly.
diagnostic reagents composed of human erythrocytes, 4b Return tubes/vials to refrigerator within 30 minutes of use.
simulated leukocytes and mammalian platelets
suspended in a plasma-like fluid with preservatives. EXPECTED RESULTS
PRECAUTIONS Verify that the lot number on the vial matches the lot
SFRi H18 controls are intended for in vitro number on the table of assay values. Assay values are
diagnostic use only by trained personnel. determined on well-maintained, properly calibrated
WARNING instruments using the instruments manufacturer’s
recommended reagents. Reagent differences,
POTENTIAL BIOHAZARDOUS MATERIAL: This
maintenance, operating technique, and calibration may
product contains human-sourced and/or potentially
contribute to the inter-laboratory variation.
infectious components. For specifics please refer to the
REAGENT section of this package insert. Components Performance Characteristics
from human donors used in preparation of this product Assigned values are presented as a Mean and Range. The Mean
were tested by FDA approved methods for the presence is derived from replicate testing on SFRi H18 instruments
of the antibodies to Human Immunodeficiency Virus operated and maintained according to Abaxis instructions. The
(HIV-1 and HIV-2) and Hepatitis C Virus (HCV), as well Range is an estimate of variation between laboratories and also
as for Hepatitis B Virus surface antigen and found to be takes into account inherent imprecision of the method and
negative. No Known method can offer complete expected biological variability of the control material. Assay
assurance that products derived from human sources or values on a new lot of control should be confirmed before the
containing inactivated microorganism will not transmit new lot is put into routine use. Test the new lot when the
infection. When handling or disposing of product, follow instrument is in good working order and quality control results on
precautions for patient specimens as specified by the the old lot are acceptable. The laboratory’s recovered mean
OSHA Blood-borne Pathogen Rule (OSHA 29 CFR should be within the assay range. For greater control sensitivity
1910.1030) or equivalent biosafety procedure. each laboratory should establish its own mean and acceptable
STABILITY AND STORAGE range and periodically reevaluate the mean. The laboratory range
may include values outside of the assay range. The used may
Store HM5 controls upright at 2-8° C (35-46° F) when not establish assay values not listed on the assay sheet, if the control
in use. Protect vials from overheating and freezing. is suitable for the method.
Unopened vials are stable through the expiration date.
Opened vials are stable for 14 days or more, provided
they are stored and handled properly.
INDICATION OF DETERIORATION Limitations
After mixing, product should be similar in appearance to The performance of this product is assured only if it is
fresh whole blood. In unmixed tubes/vials, the properly stored and used as described in this insert.
supernatant may appear cloudy and reddish; this is Incomplete mixing of a tube/vial prior to use invalidates
normal and doesn’t indicate deterioration. Other both the sample withdrawn and any remaining material in
discoloration, very dark red supernatant or unacceptable the tube/vial.
results may indicate deterioration. Do not use the Technical Assistance and customer service
product if deterioration is suspected. For assistance in resolving control recovery problems,
INSTRUCTION FOR USE for additional information, or to place an order please
1 Remove tubes/vials from the refrigerator and call our Technical Support or Customer Support
allow warming to room temperature (15 to 30°C Departments at 800-822-2947.
or 59 to 86°F) for 15 minutes before mixing.