Safety Data Sheet S¥SMEX EUROPE GMBH Sysmex
according Directive 91/1SS/EEC sun
Date of issue: 27-Sep-00 page 1 of 3
1. Identification of the substance / preparation and the company
Information of the substance or preparation
“Trade name: — EIGHTCHECK:
Variations: Low, Normal, and High Levels
Information about the manufacturer / supplier
Manufacturer: ‘SYSMEX CORPORATION
‘C.P.O.Box 1002,Kobe 650-8691, Japan
Distributor: SYSMEX EUROPE GMBH
Bornbarch 1, D-22848 Norderstedt, Germany
Enquiry point: Regulatory Affairs, Tel: 0049-(0)40-52726-0 / fax: 0049-(0)40-52726 100
7. Composition /information on ingredients ~~
Synonyms
‘Whole Blood Hematology Control
Components
‘Stabilised human erythrocytes, white blood cells, nd simulated platelets ina biological salt solution.
‘RET-CHECK: additional Fluoresceine isothiocyanate at < 0.1 % conceotration.
Hazardous ingredients
‘Not applicable
2. Possible hazards
‘Not applicable
‘All components from hurtan sourees have been tested by FDA approved methods and found to be negative for
Hepatitis B Surface Antigen and noa-reactive for HIV (HIV-1/HIV-2) and Hepatitis C antibodies. Because no
test method can offer complete assurance that human pathogens are absent, this product should be handled at the
Biosafety Level 2 as recommended for any potentially infectious human serum or blood specimen in the
CDCINIH manval "Biosafety in Microbiological and Biomedical Laboracories”, 1986.
4, First-aid measures
‘After skin contact: Rinse contacted area with water. Remove contaminated clothes
After eye contact: Flush with copious amounts of water keeping eyelid open (> 10 min.).
After ingestion: Drink lot of water, make vomiting. If symptoms persist contact a
physician
5, Fire-fighting measures
‘Suitable extinguishing methods: In accordance with those identified by the surroundings.
‘Special exposure hazards: unknown
‘Additional information: not inflammable“Sysmex Safety Data Sheet Dats ofissve 27.08.00
Tradename: - EIGHTCHECK page 2 0f3
6. Accidental release measures
Personal precautions
‘Wear gloves and laboratory coat. Prevention of skin and eye contact.
Methods for cleaning up
Use of absorbent material (e.g. silica) which should be disposed in a biohazard container. Clean with water.
Disinfect spill area.
). Handling and storage
Handling
Avoid contact with the eyes, skia, and clothing,
Storage
‘Store at temperature and conditions as indicated on the product label
| 8. Exposure controls / personal protection
Workplace-related threshold limits
‘Use genecal room ventilation.
Personal protection
Respiratory protection: not necessary
Hand protection: recommended
Eye protection: recommended
9. Physieo-chemical properties
Form: quid
Colour: red, bloodslike
Odour: one
pa: (nee) 7 (approximately)
Melting point: na.
Boiling point: na.
Flash point na
Ignition temperature: oa.
Expiosion limsts lower: na
upper: na
Density: (20°C) not determined
Solubility in water: (20°) soluble
10, Stability and reactivity
Conditions to avoid
None determined
Materials 10 avoid
None identified
Hazardous decomposition products
Not determined12, ological informanon
Information about elimination (persistence and degradability)
‘No information available
Behaviour in environmental compartments
No information avaitable
Ecotoxicological effects
‘No information available
Further information relating to ecology
None
13. Disposal considerations
Product
Ja the EU there are no uniform regulations regarding disposal of potentially fafectious materials. Laws or
‘ordinances in countries of the EU regulate theie disposal,
Please contact the responsible office (authority or Waste management company) to get detailed information,
Packing
‘Disposal according tothe authorities recommendation.
14, Transport information
Transport / further information
‘This preparation does not represent a dangerous item with regard to any mode of anspor.
15. Regulations
Labelling according to the EU Directives
not applicable
16. Other information
Reason of revision
General revision combined with software update.
Date of last revision: 27-Sep-00 Replaces edition of: 2-May-00
Information of this Safty Data Sheer represents the today's ste of our Inowledge
‘The purpose is to characterize the produc regarding safety precautions having 10 be
eo hks dosament wil no be a cemiicnton of features and will not be the bass of &
vega commas