ERBA ELite 3 - Page 74

Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ
e-mail: diagnostics@erbamannheim.com, www.erbalachema.com
Erba Lyse-Diff
Lysing reagent for automated analyzers
Name Cat. No. Package volume
Erba Lyse-Di󰀨 HEM00007 (opened) 1 L
Erba Lyse-Di󰀨 HEM00008 (closed) 1 L
For in vitro diagnostic use only
INTENDED USE
Erba Lyse-Di󰀨 lysing reagent is a stabilized and micro-l-
tered lysing agent for stromatolysis of erythtrocytes (RBC),
for quantitative determination of leukocytes (WBC), leukocyte
three-part di󰀨erentiation (LYM, MID, GRAN) and hemoglobin
(HGB) concentration measurement in human blood on hema-
tology analyzer.
Erba Lyse-Di󰀨 lysing reagent should be used with only Erba
Lachema reagents. Erroneous results may be obtained if the
reagent is applied with third party reagents.
Please refer to the instrument’s User Manual for further in-
formation.
INGREDIENTS
Surfactants < 3.5 %
Bu󰀨ers < 1.0 %
Preservative < 0.5 %
Stabilizers < 0.5 %
in ion-free water
HANDLING PRECAUTIONS
- Erba Lyse-Di󰀨 lysing reagent is environmental friendly,
cyanide-free and azide-free reagent; does not contain harm-
ful ingredients.
- Avoid contact with eyes, skin and clothing.
- In case of eye or skin contact ush eyes with copious
amounts of water for several minutes or wash skin area with
water.
- Keep the reagent container closed when not in use.
- Wear laboratory gloves when handling the reagent.
- All body uid samples should be considered potentially
infectious materials. Treat all blood and other potentially in-
fectious materials with appropriate precautions. Use gloves,
masks and gowns if blood exposure is anticipated.
- Use Good Laboratory Practices (GLP) when handling the
reagents.
SPECIMEN COLLECTION AND PREPARATION
- Erba Lyse-Di󰀨 lysing reagent is intended for use with blood
specimens collected by vein puncture in EDTA anticoagulant.
Specimens for hematological analysis may be stored for up
to 8 hours at (+15 to +30) ºC or up to 24 hours after collection
when refrigerated (+2 to +8) ºC.
REAGENT PREPARATION
- This reagent is ready for use and can be applied straight
from the container; no special reagent preparation is necessary.
- Leave the reagent at room temperature for at least 12 hours.
REAGENT REPLACEMENT
- Person installing the reagent must be a trained laboratory
professional.
- Remove the inlet cap from the reagent container to be repla-
ced. Connect the reagent inlet to the new reagent container.
- Be sure that the colour on each tube, reagent container
label and connector in the back of the instrument match.
- Avoid any dust or microbial contamination of the tubing
and reagents. Do not pour and mix the remains of a reagent
from a container into other one.
- Prime thoroughly the new reagent and measure backgrounds
according to the instrument’s User Manual.
- When installing a new lot of reagent, recalibrate the instru-
ment as specied in your User Manual.
REAGENT STORAGE, STABILITY AND DISPOSAL
- Store Erba Lyse-Di󰀨 lysing reagent between 15 and 30°C.
- The shelf life of the Erba Lyse-Di󰀪ysing agent is 48
months from date of manufacture, if stored at the prescribed
temperature range.
- Do not use reagent beyond the expiration date printed on
the container label.
- Discard opened container after 120 days.
- Do not use reagent once frozen.
- Dispose of waste product, unused product and contamina-
ted packaging in compliance with local regulations.
IVD
Hematology reagents
Date of revision: 25. 7. 2017
See Instruction for Use
i
Catalogue Number Lot Number
Expiry date
In vitro Diagnostics
Storage Temperature Content
CONT
Manufacturer
REF
CE Mark -
Device comply with
the Directive 98/79/EC
USED SYMBOLS
IVD
50003764 50004171
HEMA/PI/09/17/B
HEMA/PI/08/17/B