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 determined12, 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